Aquestive(US:AQST)2021-05-05 15:13Financial 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]