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 ...

Aquestive Therapeutics (AQST) came out with a quarterly loss of $0.13 per share versus the Zacks Consensus Estimate of a loss of $0.12. This compares to loss of $0.03 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -8.33%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.11 per share when it actually produced a loss of $0.03, delivering a surprise of 72.73%.Over the last four qu ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-38599 Aquestive Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of ...

Exhibit 99.1 Aquestive Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update • Anaphylm™ (epinephrine) Sublingual Film pre-NDA meeting scheduled for fourth quarter 2024 • AQST-108 (epinephrine) Topical Gel pre-IND meeting scheduled for fourth quarter 2024 • Libervant® (diazepam) Buccal Film for patients aged 2-5 available through retail distribution channels • Finished third quarter 2024 with approximately $78 million of cash and reaffirms cash runway into 2026 • To host inv ...

Anaphylm™ (epinephrine) Sublingual Film pre-NDA meeting scheduled for fourth quarter 2024AQST-108 (epinephrine) Topical Gel pre-IND meeting scheduled for fourth quarter 2024Libervant® (diazepam) Buccal Film for patients aged 2-5 available through retail distribution channelsFinished third quarter 2024 with approximately $78 million of cash and reaffirms cash runway into 2026To host investment community conference call at 8:00 am ET on November 5, 2024 WARREN, N.J., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Aquestiv ...

Announces completion of enrollment in its oral allergen challenge study for the development of its late-stage pipeline program, Anaphylm™ (epinephrine) Sublingual FilmOutlines the development strategy for the Company’s next pipeline product candidate, AQST-108 (epinephrine) Topical Gel for the treatment of Alopecia areataHolds virtual investor day WARREN, N.J., Sept. 27, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing me ...