Aquestive Therapeutics, Inc. (NASDAQ:AQST) Q3 2021 Earnings Conference Call November 3, 2021 8:00 AM ET Company Participants Bennett Watson - IR Keith Kendall - President & CEO Ernie Toth - CFO Dan Barber - COO Conference Call Participants Evan Hua - BMO Capital Markets Jason Butler - JMP Securities Thomas Flaten - Lake Street Capital Andreas Argyrides - Wedbush Ram Selvaraju - H.C. Wainwright Operator Good morning, and welcome to the Aquestive Therapeutics Third Quarter 2021 Conference Call. At this time, ...

Product 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].

Aquestive Therapeutics, Inc. (NASDAQ:AQST) Q2 2021 Earnings Conference Call August 4, 2021 8:00 AM ET Company Participants Stephanie Carrington - IR Keith Kendall - President & CEO Ernie Toth - CFO Ken Marshall - SVP, CCO Dan Barber - COO Conference Call Participants Evan Seigerman - BMO Capital Markets Jason Butler - JMP Securities Daniel Busby - RBC Capital Markets Thomas Flaten - Lake Street Capital Andreas Argyrides - Wedbush Ram Selvaraju - H.C. Wainwright Operator Good day and thank you for standing b ...

Financial Data and Key Metrics Changes - Total revenues for Q1 2021 were $11.1 million, up from $8.8 million in Q1 2020, reflecting a year-over-year increase of 26% [20] - Net loss for Q1 2021 was $14.7 million, or $0.41 loss per share, compared to a net loss of $16.5 million, or $0.49 loss per share in Q1 2020, indicating an improvement in loss [20] - Adjusted EBITDA loss was $6.3 million in Q1 2021, down from $11.2 million in Q1 2020, showing a significant reduction in losses [21] Business Line Data and Key Metrics Changes - SYMPAZAN, the company's proprietary product, saw a net revenue growth of 56% year-over-year in Q1 2021, with prescriptions shipped to pharmacies growing nearly 13% quarter-over-quarter and 40% year-over-year [15] - The company continues to focus on the resubmission of the NDA for Libervant, with no revenue from Libervant included in the full-year 2021 guidance until approval is certain [18] Market Data and Key Metrics Changes - The overall epilepsy market consists of approximately 3.2 million patients, with about 1.2 million having refractory disease, presenting a substantial market opportunity for Libervant [29] - SYMPAZAN's prescriber base has grown, achieving over 30% penetration into the company's focused group of prescribers, with approximately 80% of those prescribers writing multiple scripts [15] Company Strategy and Development Direction - The company is focused on two key value drivers: the resubmission and potential launch of Libervant and the continued development of its epinephrine program [18] - The company aims to launch Libervant as soon as possible after FDA approval, emphasizing the product's potential to provide a non-invasive treatment option for patients with refractory epilepsy [12][16] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the ongoing uncertainties due to the COVID-19 pandemic but remains optimistic about the company's growth trajectory and product pipeline [5] - The company expects to continue growing SYMPAZAN and is preparing for the potential launch of Libervant, with a focus on maintaining strong relationships with prescribers [16][60] Other Important Information - The company reaffirmed its full-year 2021 financial guidance, expecting total revenues of approximately $38 million to $42 million and a non-GAAP adjusted EBITDA loss of approximately $42 million to $45 million [21] - As of March 31, 2021, cash and cash equivalents were $27.5 million, with access to approximately $57.1 million under the ATM facility [21] Q&A Session Summary Question: Could the additional work for Libervant help in showing meaningful improvements in patient care and getting orphan drug designation? - Management indicated that the totality of the package, including safety and PK modeling, will drive value and market access [24][25] Question: What is the size of the market opportunity for Libervant and how does it compare to competing products? - The market opportunity is substantial, with a significant number of patients needing rescue strategies, and Libervant differentiates itself as an orally administered medicine compared to nasal alternatives [26][29] Question: How predictive were the preclinical data for AQST-108 in initial human studies? - Preclinical data for AQST-108 was very predictive, showing solid absorption and rapid conversion into epinephrine [31][32] Question: What are the expectations for SYMPAZAN revenue growth in 2021? - Management expects continued quarter-over-quarter growth for SYMPAZAN, driven by in-person interactions with healthcare providers [58]

Product 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].

Aquestive Therapeutics, Inc. (NASDAQ:AQST) Q4 2020 Earnings Conference Call March 10, 2021 8:00 AM ET Company Participants Stephanie Carrington - Investor Relations Keith Kendall - President and Chief Executive Officer Ernie Toth - Interim Chief Financial Officer Daniel Barber - Senior Vice President and Chief Operating Officer Conference Call Participants Gary Nachman - BMO Capital Markets Randall Stanicky - RBC Capital Markets Shveta Dighe - Wedbush Securities Jason Butler - JMP Securities Thomas Flaten - ...