Aquestive Therapeutics, Inc. (NASDAQ:AQST) is one of the stocks Jim Cramer recently put under a microscope. When a caller asked about the stock, Cramer stated: “We know the problem. Let’s not look at that. We look at the pipeline and we know that… I’m in favor of investing in a spec of any company involving nervous system, okay? Any company involving the brain and they’re there, and I think it’s a very interesting spec.” Photo by Joshua Mayo on Unsplash Aquestive Therapeutics, Inc. (NASDAQ:AQST) devel ...

On CNBC's “Mad Money Lightning Round,” Jim Cramer said Aquestive Therapeutics, Inc. (NASDAQ:AQST) is a “very interesting spec.”Piper Sandler analyst David Amsellem, on Nov. 7, maintained Aquestive Therapeutics with an Overweight rating and raised the price target from $5 to $8.Amphenol Corporation (NYSE:APH) is such a “great” stock, Cramer said. “You want to stay in that cable play.”Supporting his view, Amphenol reported better-than-expected fiscal third-quarter 2025 results on Oct. 22. Quarterly sales incr ...

Group 1 - The presentation is led by David Amsellem from Piper Sandler's Biopharma research team, focusing on the third quarter earnings cycle for Aquestive Therapeutics [1] - The senior leadership team of Aquestive Therapeutics is present, including the President and CEO, CFO, Chief Medical Officer, and other key executives [2] - The ACAAI meeting in Florida is highlighted as an important event where data related to Anaphylm will be presented in the coming days [2]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 increased by $0.5 million, or 4% year over year, to $12.8 million, excluding the impact of one-time recognition of deferred revenue in Q3 2024 [19][25] - Net loss for Q3 2025 was $15.4 million, or $0.14 per share, compared to a net loss of $11.5 million, or $0.13 per share in Q3 2024 [24][25] - Non-GAAP adjusted EBITDA loss was $8.6 million in Q3 2025, compared to a loss of $6.6 million in Q3 2024 [25] Business Line Data and Key Metrics Changes - Manufacturer and supply revenue increased to $11.5 million in Q3 2025 from $10.7 million in Q3 2024, primarily due to increases in Sympazan and Suboxone revenues [19] - Research and development expenses decreased to $4.5 million in Q3 2025 from $5.3 million in Q3 2024, mainly due to lower clinical trial costs associated with the Anafilm program [20][21] - Selling, general, and administrative expenses increased to $15.3 million in Q3 2025 from $12.1 million in Q3 2024, driven by higher pre-commercial spending and legal fees [22][23] Market Data and Key Metrics Changes - The market for epinephrine products grew by almost 9% last quarter, with a significant portion of growth coming from autoinjectors [29][56] - 95% of prescriptions in the epinephrine market are for autoinjectors, indicating a strong focus for the company’s strategy [41][56] Company Strategy and Development Direction - The company is focused on launching Anafilm, the first oral medication for severe allergic reactions, with a scheduled FDA action date of January 31, 2026 [7][8] - Plans to exploit the science behind the Adrenoverse platform are underway, with a focus on advancing R&D efforts in 2026 [10][12] - The company aims to establish partnerships for international distribution of Anafilm, with filings anticipated in Canada and Europe in 2026 [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the FDA review process and the readiness for a potential launch of Anafilm in Q1 2026 [10][40] - The company is well-positioned financially to support the launch of Anafilm, having completed significant equity and commercial launch financing [17][25] - Management highlighted the importance of patient access and pricing strategy, emphasizing a patient-first approach [33][34] Other Important Information - The company has made leadership changes to better support the launch of Anafilm and the development of the Adrenoverse platform [11] - The company’s manufacturing operations remain stable, with a focus on maintaining supply chain reliability [18] Q&A Session Summary Question: Any new comments on your competitor's citizens' petition? - Management believes the petition indicates competitor concern about the market entry of Anafilm and has seen no impact on the FDA review process [30][32] Question: How are you thinking about pricing relative to the nasal spray and the generic EpiPen? - The company plans to price Anafilm responsibly with a patient-first approach, ensuring broad access through various programs [33][34] Question: How do you think about the optimal timing for partnerships outside the U.S.? - The company is actively engaging in partnership discussions and believes that closer proximity to regulatory approvals will enhance product value [36] Question: What are the key aspects of product profiles that physicians focus on? - Physicians prioritize efficacy, safety, and the convenience of administration, with a strong interest in the product's pharmacokinetics [59] Question: Can you discuss the importance of the new patents for Anafilm? - The new patents are crucial for strengthening the overall patent portfolio and protecting the product's market position [62]

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh. ...

Third Quarter 2025 Earnings Supplemental Materials September 2024 November 5, 2025 Solving problems. Improving lives. Advancing medicines. Disclaimer Certain statements in this press release include "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 similar expressions, are intended to identify forward-looking statements. Thes ...

For the quarter ended September 2025, Aquestive Therapeutics (AQST) reported revenue of $12.81 million, down 5.4% over the same period last year. EPS came in at -$0.14, compared to -$0.13 in the year-ago quarter.The reported revenue represents a surprise of -4.13% over the Zacks Consensus Estimate of $13.36 million. With the consensus EPS estimate being -$0.13, the EPS surprise was -7.69%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare ...

Company Performance - Aquestive Therapeutics reported a quarterly loss of $0.14 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.13, representing an earnings surprise of -7.69% [1] - The company posted revenues of $12.81 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 4.13% and down from $13.54 million a year ago [2] - Over the last four quarters, the company has only surpassed consensus EPS estimates once and has not beaten consensus revenue estimates [2] Stock Movement and Outlook - The stock has increased approximately 70.8% since the beginning of the year, significantly outperforming the S&P 500's gain of 15.1% [3] - The future price movement of the stock will largely depend on management's commentary during the earnings call and the earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.14 on revenues of $14.03 million, and for the current fiscal year, it is -$0.63 on revenues of $46.1 million [7] Industry Context - The Medical - Drugs industry, to which Aquestive Therapeutics belongs, is currently in the top 40% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Product Development - Anaphylm™ (dibutepinephrine) Sublingual Film is being developed as the first non-device based, orally delivered epinephrine product candidate, showing clinical results comparable to auto-injectors for treating anaphylaxis [167]. - In March 2024, the pivotal clinical study for Anaphylm met its primary endpoint of epinephrine PK biocomparability with IM injection and autoinjectors, demonstrating safety and tolerability [173]. - The pivotal clinical study commenced in Q4 2023, incorporating FDA feedback on protocol design, sample size, and statistical analysis [171]. - Positive topline data from a temperature/pH study of Anaphylm showed no statistically significant difference in PK and PD results based on temperature and pH variability [174]. - In October 2024, positive topline data from the OASIS study showed a median time to complete symptom resolution of 12 minutes post-Anaphylm administration, compared to 74 minutes at screening baseline [177]. - The pediatric study for Anaphylm, involving 32 patients aged 7 to 17, reported consistent PK results with previous adult studies and no serious adverse events [180]. - Anaphylm's PK profile showed median Tmax maintained at 12 minutes, with rapid symptom resolution observed in 94% of subjects after allergen exposure [177]. - The company is focused on addressing large market opportunities with its complex molecule pipeline, including the Anaphylm and Adrenaverse™ platforms [167]. Regulatory Approvals - The FDA granted Fast Track designation for Anaphylm in March 2022, and the 505(b)(2) regulatory approval pathway was confirmed as acceptable [169]. - The FDA accepted the NDA submission for Anaphylm on June 16, 2025, with a PDUFA target action date of January 31, 2026 [181]. - The FDA confirmed that an advisory committee meeting would not be required for Anaphylm, streamlining the approval process [182]. - The company received positive pre-NDA feedback from the FDA, indicating no additional adult clinical trials would be necessary for the NDA submission [179]. - The company is pursuing regulatory strategies for Anaphylm outside the United States, including discussions with Health Canada and the EMA [181]. Financial Performance - The company generated $31,530 and $45,694 in revenue from its licensed product portfolio for the nine months ended September 30, 2025, and 2024, respectively [191]. - Total revenues for the three months ended September 30, 2025, decreased by 5%, or $735, compared to the same period in 2024, primarily due to decreases in license and royalty revenue [223]. - Manufacture and supply revenue increased by approximately 7%, or $796, for the three months ended September 30, 2025, driven by a $395 increase in Sympazan revenues and a $380 increase in Suboxone revenues [224]. - License and royalty revenue decreased by 52%, or $1,124, for the three months ended September 30, 2025, primarily due to the one-time recognition of deferred revenue of $1,227 from a terminated licensing agreement [225]. - Total revenues for the nine months ended September 30, 2025, decreased by 31%, or $14,164, compared to the same period in 2024, mainly due to decreases in license and royalty revenue and manufacture and supply revenue [228]. - License and royalty revenue for the nine months ended September 30, 2025, decreased by 82%, or $11,847, primarily due to the one-time recognition of deferred revenues of $11,544 from terminated licensing agreements [230]. Research and Development - R&D expenses are expected to remain significant as the company develops existing product candidates and identifies new opportunities [210]. - Research and development expenses decreased by 14%, or $739, for the three months ended September 30, 2025, primarily due to lower clinical trial costs associated with the Anaphylm program [236]. - R&D share-based compensation increased by $1,000, or 323%, primarily due to acceleration of compensation related to severance [239]. - R&D personnel costs increased by 10% or $464 for the nine months ended September 30, 2025, mainly due to one-time severance expenses [248]. - R&D expenses decreased by 9% or $1,367 for the nine months ended September 30, 2025, mainly due to a reduction in clinical trial costs associated with the Anaphylm program [246]. Cost Management - The company is managing costs in preparation for a potential decline in Suboxone revenue and focusing on regulatory activities for Anaphylm [213]. - Selling, General and Administrative expenses include costs related to executive compensation, legal fees, and market research [211]. - Selling, general and administrative expenses increased by 38% or $12,856 for the nine months ended September 30, 2025, primarily due to higher commercial spending of approximately $5,950 for Anaphylm launch and regulatory fees of approximately $4,310 [249]. Financing Activities - The company sold 7,457,627 shares of Common Stock under the ATM facility for net proceeds of approximately $21,261 for the nine months ended September 30, 2025 [256]. - The company completed a public offering of 21,250,000 shares at $4.00 per share, resulting in net proceeds of $79,900 after underwriting discounts [263]. - Net cash provided by financing activities rose to $101,957 thousand, up from $83,435 thousand in the prior year, driven by net proceeds from the public offering and higher ATM proceeds [267]. - The company expects to incur significant operating losses and negative cash flows for the foreseeable future, indicating a reliance on external financing to achieve its operating plan [270][271]. - The company has utilized existing cash and equivalents for product pipeline development and working capital, with no assurance that future funding will be available on reasonable terms [269]. Debt and Interest - Interest expense consists of costs on the outstanding balances of 13.5% Notes, payable quarterly [215]. - The company has substantial ongoing interest payments and principal repayments related to its 13.5% Notes starting in June 2026, with a significant portion of revenues dependent on a single customer, Indivior [273]. - Interest expense related to royalty obligations increased by 5%, or $74, for the three months ended September 30, 2025, compared to the same period in 2024 [234]. - Interest expense was $8,342 for the nine months ended September 30, 2025, compared to $8,343 for the same period in 2024 [250]. - Interest income and other income, net decreased by 69%, or $673, for the three months ended September 30, 2025, compared to the same period in 2024 [234]. Cash Position - The company had $129,063 in cash and cash equivalents as of September 30, 2025, providing liquidity for operating needs for at least the next twelve months [254]. - For the nine months ended September 30, 2025, net cash used for operating activities increased to $(43,963) thousand from $(29,270) thousand in the prior year, primarily due to a net loss increase of $24,842 thousand [264][265]. - Interest income and other income, net increased to $3,115 for the nine months ended September 30, 2025, from $2,703 in 2024, primarily due to an ERTC credit received [253].

If approved by the United States Food and Drug Administration (FDA), Anaphylm would be the first and only oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis. Aquestive believes that Anaphylm's needle-free, portable, and easy-to-administer formulation can help overcome barriers to epinephrine use and improve patient compliance in emergency situations. Exhibit 99.1 Aquestive Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update Warren, ...