Aquestive(US:AQST)2021-05-03 16:00Product Development and FDA Approvals - The company has five products approved by the FDA, including proprietary and out-licensed products, with a focus on central nervous system diseases and anaphylaxis treatment [154]. - Sympazan® has shown growth in prescriber metrics and retail shipments since its launch in December 2018, indicating strong market performance [155]. - Libervant™ is under development as a non-device delivered oral diazepam-based product for managing seizure clusters, with a resubmission of the NDA expected by the end of Q2 2021 [156]. - AQST-108-SF, an oral sublingual film for anaphylaxis, has completed a second pharmacokinetic trial, demonstrating similar pharmacokinetics to injectable epinephrine and improved patient adherence potential [157][158]. - AQST-109-SF is a next-generation formulation of epinephrine, with a single ascending dose PK study planned for the second half of 2021 [160]. - AQST-305-SF is being developed as a non-invasive alternative to Sandostatin for treating acromegaly, aiming to reduce treatment burden and healthcare costs [161]. - The company is focused on addressing FDA concerns regarding Libervant™ and aims to demonstrate its clinical superiority over existing treatments [156]. - The company anticipates a six-month review process post-resubmission of the NDA for Libervant™, contingent on FDA approval [156]. - The company is leveraging its proprietary PharmFilm® technology to develop differentiated products that meet unmet medical needs [154]. Financial Performance - Licensed product portfolio generated $40.2 million and $49.7 million in revenue for the years ended December 31, 2020 and 2019, respectively [162]. - Suboxone branded products retain approximately 40% film market share as of January 31, 2021, with over 2.2 billion doses produced since its launch in 2010 [162]. - KYNMOBI generated $50.0 million in gross proceeds through a monetization agreement, with potential total gross proceeds of $125.0 million [166]. - Total revenues increased by 27% or $2,357 to $11,122 for the three-month period ended March 31, 2021, compared to $8,765 for the same period in the prior year [198]. - License and royalty revenue surged by 454% or $1,935 to $2,361 for the three-month period ended March 31, 2021, due to the recognition of deferred revenue from a terminated agreement [200]. - Proprietary product sales, net increased by 56% or $652 to $1,812 for the three-month period ended March 31, 2021, reflecting improved acceptance of Sympazan in the medical community [201]. Cost Management and Expenses - Manufacture and supply costs decreased by 25% or $902 to $2,757 for the three-month period ended March 31, 2021, primarily due to lower production volumes of Suboxone [204]. - Research and development expenses decreased by 16% or $695 to $3,659 for the three-month period ended March 31, 2021, driven by the timing of clinical trial activities [204]. - Selling, general and administrative expenses decreased by 9% or $1,382 to $13,231 for the three-month period ended March 31, 2021, attributed to lower marketing costs for Sympazan [204]. - The company expects to continue to manage costs in response to declining Suboxone volumes and to support the commercialization of proprietary products [184]. - The company plans to manage business costs in light of potential declining Suboxone revenue and focus on ongoing product development for Libervant, AQST-108-SF, and AQST-109-SF [220]. Cash Flow and Liquidity - Net cash used for operating activities for the three-month period ended March 31, 2021 was $14,097, compared to $13,637 for the same period in 2020 [212][213]. - Net cash provided by financing activities was $9,891 for the three-month period ended March 31, 2021, compared to a net cash used of $37 during the same period in 2020 [215]. - The company expects existing cash and cash equivalents, along with anticipated revenues, to be adequate to fund cash requirements for the next 12 months [216]. - The company may need to engage in expense management activities if adequate funds are not available for liquidity needs [224]. Operational Impact of COVID-19 - The ongoing impact of the COVID-19 pandemic poses risks to clinical trials, regulatory submissions, and overall business operations [152]. - The company continues to manufacture and supply products without significant interruption despite the COVID-19 pandemic [169]. - The company has maintained appropriate staffing levels at laboratory and manufacturing sites while adapting sales and marketing practices to remote interactions [170]. Other Financial Obligations - The company has principal repayments aggregating $2,575 related to its 12.5% Notes due in the second half of 2021 [222]. - The company did not have any material off-balance sheet arrangements during the period presented [226].