Aquestive(US:AQST)2025-11-05 21:07Product 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].