Aquestive(US:AQST)2021-11-01 16:00Product Development and FDA Approvals - The company has five products approved by the FDA, including Sympazan and Libervant, with a focus on addressing unmet medical needs in CNS diseases [141]. - Sympazan, launched in December 2018, continues to show growth in prescriber metrics and retail shipments [142]. - Libervant is under FDA review with a PDUFA target goal date of December 23, 2021, following a resubmission of its NDA [143]. - AQST-109, a sublingual film formulation of epinephrine, has completed a Phase 1 clinical trial in Canada, showing safety and tolerability comparable to auto-injectors [145]. - AQST-108, another sublingual formulation, is in development for allergic reactions and has shown a favorable safety profile in a recent Phase 1 trial [146]. - AQST-305, a sublingual film formulation of octreotide for acromegaly treatment, is being prepared for additional research trials [148]. - The company is focused on commercializing Sympazan and advancing its product pipeline, including Libervant, AQST-109, and AQST-108 [141]. - The anticipated launch of Libervant is contingent upon FDA approval, with the current commercial organization prepared to initiate the launch shortly after approval [175]. Financial Performance and Revenue - The licensed product portfolio generated $40.2 million in revenue for the year ended December 31, 2020, down from $49.7 million in 2019, indicating a decline of approximately 19.8% [149]. - Total revenues for the three months ended September 30, 2021, increased by 61% to $13,287, compared to $8,260 in the same period of the prior year, primarily driven by higher manufacturing and supply revenue [181]. - Manufacturing and supply revenue rose by 77% to $10,447 for the three months ended September 30, 2021, compared to $5,903 in the same period of the prior year, attributed to increased Suboxone manufacturing volume [182][183]. - License and royalty revenue decreased by 63% to $5,000 for the nine months ended September 30, 2021, compared to $13,682 in the same period of the prior year, due to the absence of a milestone earned in the previous year [184]. - The company expects future manufacture and supply revenue to be based on volume demand for existing licensed products and new agreements for successful product development collaborations [164]. Operating Expenses and Cash Flow - Research and development expenses decreased by 35% to $4,726 for the three months ended September 30, 2021, compared to $7,260 in the same period of the prior year, driven by the timing of clinical trial activities [188]. - Selling, general and administrative expenses increased by 3% to $12,129 for the three months ended September 30, 2021, compared to $11,803 in the same period of the prior year, primarily due to litigation expenses [189]. - Interest expense related to the sale of future revenue was $3,767 for the three months ended September 30, 2021, reflecting the accounting associated with the sale of future revenue related to KYNMOBI® [190]. - The company had $31,164 in cash and cash equivalents as of September 30, 2021, amidst a history of net losses totaling $227,851 [191]. - Net cash used for operating activities decreased by $7,029 to $(24,918) for the nine months ended September 30, 2021, compared to $(31,947) in the prior year [198]. - Net cash provided by financing activities increased by $24,689 to $24,655 for the nine months ended September 30, 2021, primarily due to net proceeds from the sale of shares under the ATM facility [201]. Market Competition and Risks - The company faces risks related to FDA approval processes and potential competition for its product candidates [138]. - The ongoing COVID-19 pandemic may impact clinical trials, regulatory submissions, and overall business operations [139]. - Suboxone retains approximately 38% market share in the film category as of September 30, 2021, despite increased competition from generic products [149]. - The company plans to manage business costs in light of anticipated declines in Suboxone revenue and to focus on ongoing product development for Libervant, AQST-109, and AQST-108 [204]. Strategic Partnerships and Future Outlook - The company is seeking a new partner to commercialize Zuplenz in the United States after regaining rights following Fortovia's bankruptcy [154]. - The company expects to continue significant research and development expenses as it develops existing product candidates and identifies new ones [173]. - The company anticipates that the sufficiency of its liquidity will be impacted by operating revenues and the timely achievement of regulatory approvals for its proprietary products [205]. - The company may need to engage in expense management activities, including reducing staff or scaling back research and development programs, if adequate funds are not available [208].