WARREN, N.J., Aug. 14, 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 the pricing of an underwritten offering of 21,250,000 shares of its common stock at an offering price of $4.00 per share. The gross proceeds of the offering to Aquestive, before deducting the underwriting discounts and com ...

Aquestive Therapeutics (AQST) Q2 2025 Earnings Call August 12, 2025 08:00 AM ET Speaker0Good day, and thank you for standing by. Welcome to the Aquestive Therapeutics Second Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in listen only mode. After the speakers' presentation, there'll be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone.You will then hear an automated message advising your hand is raised. ...

Anaphylm (Epinephrine) Sublingual Film - FDA accepted the NDA for Anaphylm in Q2 2025, with a PDUFA date scheduled for January 31, 2026[8] - The company is preparing for a U S launch of Anaphylm in Q1 2026, pending FDA approval[8] - A pediatric study showed that 12 mg Anaphylm administration demonstrated comparable PK curves in adult and pediatric subjects, with no statistical differences between PK parameters[16] - Pharmacodynamic (PD) outcomes in the pediatric study showed a positive inflection for Heart Rate (HR), Systolic Blood Pressure (SBP), and Diastolic Blood Pressure (DBP) after Anaphylm exposure[25] Financial Performance and Outlook - As of June 30, 2025, the company had a cash balance of approximately $60.5 million[8] - The company projects its cash runway into 2026[8] - The company is guiding for total revenues of approximately $44-$50 million for 2025[34] - The company anticipates a Non-GAAP adjusted EBITDA loss of approximately $47-$51 million for 2025[34] Manufacturing Operations - Manufacturing operations continue to generate cash[30] - Doses shipped in Q2 2025 were 37204 (thousands)[31]

Core Insights - Aquestive Therapeutics reported $10 million in revenue for Q2 2025, a year-over-year decline of 50.2% [1] - The EPS for the same period was -$0.14, compared to -$0.03 a year ago, with a surprise of +22.22% against the consensus estimate of -$0.18 [1] Revenue Breakdown - Manufacture and supply revenue was $9.58 million, exceeding the average estimate of $8.49 million, representing an 18% year-over-year increase [4] - License and royalty revenue was $0.84 million, significantly below the estimated $2.09 million, reflecting a 92.5% decline compared to the previous year [4] - Co-development and research fees amounted to $0.38 million, slightly below the estimated $0.5 million, marking a 50% decrease year-over-year [4] Stock Performance - Shares of Aquestive Therapeutics have returned -2.7% over the past month, contrasting with the Zacks S&P 500 composite's +2.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Aquestive Therapeutics (AQST) came out with a quarterly loss of $0.14 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to a 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 +22.22%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.17 per share when it actually produced a loss of $0.24, delivering a surprise of -41.18%.Over the last fou ...

For the transition period from _____ to _____ 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 June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-38599 Aquestive Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of Incor ...

Exhibit 99.1 Aquestive Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update Warren, N.J., August 11, 2025 – 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 financial results for the second quarter ended June 30, 2025, and provided a strategic business update. "The second quarter mar ...

Core Insights - Aquestive Therapeutics announced pivotal progress with the FDA's acceptance of the NDA for Anaphylm, which could become the first oral, sublingual film epinephrine product if approved [2][3] - The company is preparing for a potential U.S. launch in 2026 and is also engaging in regulatory discussions for global expansion in Canada and the EU [2][4] - Financial results for Q2 2025 showed total revenues of $10.0 million, a decrease from $20.1 million in Q2 2024, primarily due to the prior year's one-time revenue recognition [11][14] Regulatory and Product Development - The FDA has accepted the NDA for Anaphylm, with a PDUFA date set for January 31, 2026, and the company is preparing for an Advisory Committee meeting [3][7] - Anaphylm has completed 10 clinical studies with approximately 935 administrations across 379 subjects, addressing the unmet need for non-invasive epinephrine delivery options [3][5] - The company is also advancing AQST-108, a topical gel for alopecia areata, with an anticipated IND submission in Q4 2025 [6] Commercial Strategy - Aquestive is building a commercial launch team for Anaphylm and leveraging existing infrastructure for execution [4] - The company views international markets as critical for long-term strategy and is actively pursuing regulatory meetings in Canada and the EU [4][5] - Anaphylm is positioned to address barriers to epinephrine adoption, such as fear of needles and device complexity, potentially transforming emergency allergy treatment [5] Financial Performance - Total revenues for Q2 2025 increased by $0.3 million, or 3%, year-over-year, excluding the impact of one-time deferred revenue recognition [11] - Manufacturing and supply revenue rose to $9.6 million in Q2 2025 from $8.1 million in Q2 2024, driven by increased Ondif revenues [12] - The net loss for Q2 2025 was $13.5 million, compared to a net loss of $2.7 million in Q2 2024, primarily due to decreased revenues and increased administrative expenses [14][15] Future Outlook - The company expects total revenue for the full year 2025 to be between $44 million and $50 million, with a non-GAAP adjusted EBITDA loss projected between $47 million and $51 million [17] - Cash and cash equivalents were reported at $60.5 million as of June 30, 2025, indicating a stable financial position for ongoing operations [16]

Corporate Presentation September 2024 August 2025 Solving problems. Improving lives. Advancing medicines. Disclaimer This presentation and the accompanying oral commentary have been prepared by Aquestive Therapeutics, Inc. ("Aquestive", the "Company", "our" or "us") and contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "plan," "expect," "estimate," "intend," "may," "will," or the negative of those terms, and ...

Core Insights - The article discusses the performance and future outlook of Aquestive Therapeutics (NASDAQ: AQST), noting a 2% decline in the stock price over the past six months since the last analysis [2]. Company Focus Areas - The company is focusing on five key areas for 2025, including the potential FDA approval of Anaphylm, which is a significant catalyst for future growth [2]. Investment Group Features - The investment group Compounding Healthcare offers several features such as model healthcare portfolios, a weekly newsletter, a daily watchlist, and a platform for dialogue and questions among members [2].