Core Viewpoint - Aquestive Therapeutics, Inc. is set to report its fourth quarter results for the period ending December 31, 2024, and will provide updates on recent business developments on March 5, 2025, after market close [1] Company Overview - Aquestive Therapeutics is a pharmaceutical company focused on advancing medicines that significantly improve patients' lives through innovative science and delivery technologies [4] - The company is developing orally administered products to deliver complex molecules, offering alternatives to invasive and inconvenient standard therapies [4] - Currently, Aquestive has five commercialized products marketed in the U.S. and globally, and it is the exclusive manufacturer of these licensed products [4] - The company collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies, such as PharmFilm® [4] - Aquestive is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis, and an earlier stage epinephrine prodrug topical gel for various dermatological conditions, including alopecia areata [4] Upcoming Events - Management will host a conference call for investors on March 6, 2025, at 8:00 a.m. ET, with registration required for participation [2] - A live webcast of the call will be available on the Investors section of the company's website [2] - A replay of the webcast will be accessible for 30 days following the call [3]

Core Viewpoint - Aquestive Therapeutics is advancing its investigational product Anaphylm, an epinephrine sublingual film, aimed at providing a reliable and portable treatment for severe allergic reactions, including anaphylaxis, with results to be presented at the 2025 AAAAI Annual Meeting [1][2]. Group 1: Product Development and Clinical Data - Anaphylm is designed to offer a more accessible option for emergency epinephrine administration without the need for an injection or device, pending FDA approval [2]. - The Phase 2 OASIS study involved 36 adults with Oral Allergy Syndrome, demonstrating that Anaphylm maintains stability and potency under extreme conditions, which is crucial for real-world application [2][4]. - Anaphylm showed consistent epinephrine absorption and matched or exceeded intramuscular (IM) epinephrine in key pharmacokinetic parameters, with median symptom resolution time of 12 minutes compared to 74 minutes without treatment [5][4]. Group 2: Presentation Details - Multiple posters will be presented at the AAAAI Annual Meeting, including topics on the durability of Anaphylm under real-world use, stability under extreme temperature conditions, and pharmacokinetic and pharmacodynamic responses [3][6]. - The lead authors for the presentations include Steve Wargacki, PhD, and Carl N. Kraus, MD, with specific presentation times scheduled for March 1, 2025 [3][6]. Group 3: Company Overview - Aquestive Therapeutics focuses on advancing medicines through innovative science and delivery technologies, with a portfolio that includes five commercialized products and collaborations with other pharmaceutical companies [8]. - The company is also developing an earlier-stage epinephrine prodrug topical gel for various dermatology conditions, showcasing its commitment to addressing complex medical needs [8].

Core Insights - Aquestive Therapeutics, Inc. will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference virtually on February 11-12, 2025, with a fireside chat scheduled for February 11 at 3:20 PM ET [1] Company Overview - Aquestive is a pharmaceutical company focused on advancing medicines that improve patients' lives through innovative science and delivery technologies [3] - The company is developing orally administered and topical gel products to deliver complex molecules, providing alternatives to standard therapies [3] - Currently, Aquestive has five commercialized products marketed in the U.S. and globally, and it is the exclusive manufacturer of these licensed products [3] - The company collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm [3] - 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 [3]

Core Insights - Aquestive Therapeutics is focused on advancing innovative medicines to improve patients' lives through unique delivery technologies and has outlined key objectives for 2025 [1][2] Group 1: Business Developments - In 2024, the company achieved significant milestones, positioning it for continued success in 2025, including the potential approval and launch of Anaphylm, Libervant, and AQST-108 [2] - The company plans to submit the New Drug Application (NDA) for Anaphylm in the first quarter of 2025, aiming to address unmet needs in severe allergy management [4] - Libervant received FDA approval in 2024 for treating seizure clusters in pediatric patients aged two to five years, ensuring access to essential treatment for this age group [7][8] Group 2: Product Development - Anaphylm, an innovative epinephrine delivery system, is on track for NDA submission, with a successful pre-NDA meeting with the FDA and a Phase 1 pediatric trial initiated [3][4] - AQST-108, a topical gel for alopecia areata, is set to begin its Phase 2a clinical trial in the second quarter of 2025 after a supportive pre-IND meeting with the FDA [5][6] - The market opportunity for JAK inhibitors in alopecia areata is estimated to exceed one billion U.S. dollars, highlighting the potential for AQST-108 to capture market share if approved [6] Group 3: Financial Position - As of December 31, 2024, the company reported unaudited cash and cash equivalents of approximately $70 million, providing a solid financial foundation for ongoing and future projects [7]

Company Overview - Aquestive Therapeutics (NASDAQ: AQST) has transitioned from a pharmaceutical company focused on partnering or licensing its PharmFilm technology to a clinical-stage company [1] - The company has been covered by the analyst since 2019, highlighting its evolution and potential in the healthcare sector [1] Analyst's Perspective - The analyst has a beneficial long position in AQST through stock ownership, options, or other derivatives, indicating a positive outlook on the company's future [2] - The article reflects the analyst's personal opinions and is not influenced by compensation or business relationships with the mentioned companies [2] Industry Focus - The analyst specializes in innovative companies developing breakthrough therapies and pharmaceuticals, with a focus on potential acquisition catalysts [1] - The healthcare investment group led by the analyst offers several model healthcare portfolios, a weekly newsletter, a daily watchlist, and a chat for dialogue and questions [1]

Core Points - The U.S. FDA has granted seven years of orphan drug exclusivity to Libervant® (diazepam) Buccal Film for treating seizure clusters in pediatric patients aged 2 to 5 [1] - Libervant is the first and only FDA-approved orally administered rescue therapy for this specific patient population [2] - The FDA's orphan designation provides financial incentives and market exclusivity benefits for drugs treating rare diseases affecting fewer than 200,000 people in the U.S. [1] Company Overview - Aquestive Therapeutics, Inc. is focused on advancing medicines through innovative science and delivery technologies, with a portfolio that includes five commercialized products [11] - The company aims to provide non-invasive treatment alternatives to existing therapies for patients with refractory epilepsy [3] - Libervant was originally granted Orphan Drug Designation on November 10, 2016, and the exclusivity extends to April 2031 [1] Product Details - Libervant is a buccal film formulation of diazepam intended for acute treatment of frequent seizure activity distinct from a patient's usual seizure pattern [3] - The product was approved for pediatric patients aged 2 to 5 in April 2024, following tentative approval for patients aged 12 and older in August 2022 [3] - The buccal route of administration is considered a significant improvement over the rectal route, enhancing ease of use for caregivers [1]

Financial Data and Key Metrics Changes - Total revenues increased to $13.5 million in Q3 2024 from $13 million in Q3 2023, a 4% increase primarily driven by an increase in license and royalty revenue [18] - Net loss for Q3 2024 was $11.5 million or $0.13 per share, compared to a net loss of $2 million or $0.03 per share in Q3 2023, driven by increased expenses [22] - Non-GAAP adjusted EBITDA loss was $6.6 million in Q3 2024 compared to a loss of $1.3 million in Q3 2023 [23] Business Line Data and Key Metrics Changes - Manufacture and supply revenue decreased to $10.7 million in Q3 2024 from $11.4 million in Q3 2023, primarily due to timing of revenues [18] - Research and development expenses increased to $5.3 million in Q3 2024 from $3.2 million in Q3 2023, driven by clinical trial costs [20] - Selling, general and administrative expenses increased to $12.1 million in Q3 2024 from $7.4 million in Q3 2023, influenced by increased commercial spending [21] Market Data and Key Metrics Changes - Medicaid coverage for Libervant is now available in all 50 states, enhancing market access [12] - Libervant prescriptions have steadily increased between September and October 2024 due to expanded retail distribution and a national sales team [13] Company Strategy and Development Direction - The company is focused on advancing Anaphylm towards NDA submission and growing Libervant prescriptions in the pediatric space [15] - Plans for a Phase 2a study for AQST-108 are set for 2025, targeting alopecia areata, with expectations for significant market opportunity [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made with Anaphylm and the supportive feedback received from the FDA [9][10] - The outlook for 2024 remains unchanged, with total revenues expected to be approximately $57 million to $60 million [25] Other Important Information - Cash and cash equivalents were $77.9 million as of September 30, 2024, supporting ongoing development and commercialization efforts [24] - The company is preparing for a pre-NDA meeting with the FDA and plans to share findings post-meeting [10] Q&A Session Summary Question: What topics will be highlighted in the Anaphylm clinical briefing book? - The company aims to demonstrate that they have met all FDA requirements and is looking for guidance on the completeness of their package [28] Question: How did negotiations with PBMs for Libervant go? - Negotiations have been positive, with coverage being secured for patients aged two to five [29] Question: Will there be an Ad Comm for Anaphylm? - The company is prepared for the possibility of an Ad Comm but does not have insight into the FDA's thinking [36] Question: What is the pricing paradigm for Libervant? - Pricing has not been an obstacle, and the payer community understands the necessity of the product [46] Question: How will the NDA for Anaphylm be prepared while the pediatric study is ongoing? - The NDA preparation is ongoing, and the company expects alignment with the FDA on the pediatric study design [66]

Company Overview - Aquestive Therapeutics (NASDAQ: AQST) is a small-cap pharmaceutical company founded in 2004, specializing in unique film-based medicines for various indications [1] - The company has developed the "PharmFilm" platform, which serves as an alternative to invasive delivery methods [1] Investment Interest - The primary investment interest lies in biotech, with over a decade of investment experience in this sector [1] - Secondary interests include dividend growth equities and business development companies (BDC) [1]

| --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | | | | | | | | | | | | | Third Quarter 2024 Earnings Supplemental Materials | | | | | | | September 2024 November 4, 2024 | Advancing medicines. Advancing medicines. Solving problems. S ...

Aquestive Therapeutics (AQST) reported $13.54 million in revenue for the quarter ended September 2024, representing a year-over-year increase of 4.2%. EPS of -$0.13 for the same period compares to -$0.03 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $12.69 million, representing a surprise of +6.68%. The company delivered an EPS surprise of -8.33%, with the consensus EPS estimate being -$0.12.While investors closely watch year-over-year changes in headline numbers -- revenue and ...