Zevra Therapeutics(ZVRA) - 2020 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q1 2020, KemPharm reported $2.1 million in services revenue, an increase from $1.4 million in Q4 2019, marking the third consecutive quarter of revenue [28] - The net loss for Q1 2020 was $5.8 million, or $0.12 per share, a significant improvement compared to a net loss of $12.3 million, or $0.46 per share, in Q1 2019 [29] - Total cash as of March 31, 2020, was $2.5 million, a decrease of $1.1 million from December 31, 2019 [31] - Total debt decreased to $68.6 million from $77.3 million at the end of 2019, primarily due to an exchange agreement with Deerfield [32] Business Line Data and Key Metrics Changes - Development services revenue from partners GPC and Corium has been a consistent contributor, highlighting the value of KemPharm's partnerships [8] - APADAZ, in collaboration with KVK, has made progress in a challenging opioid market, with 19 states adding its authorized generic form to their Medicaid preferred drug lists [25][26] Market Data and Key Metrics Changes - The ADHD market presents significant unmet needs, particularly in duration of action, onset of action, and potential for abuse, which KP415 aims to address [17] - KP415 is positioned as a methylphenidate version of Vyvanse, with potential features that may surpass those of Vyvanse [15] Company Strategy and Development Direction - The acceptance of the KP415 NDA by the FDA is a critical milestone, triggering a $5 million payment from GPC [7] - The company is focused on balancing cash management, risk, and potential dilution while preparing for the commercial launch of KP415 [43][44] - KemPharm is exploring collaborations for new prodrugs with Deerfield, aiming to add value through R&D cost coverage and licensing opportunities [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of KP415 and its commercial partner Corium, emphasizing the importance of the upcoming PDUFA date [40][45] - The company acknowledges the risks associated with the current market conditions and the ongoing COVID-19 pandemic but remains optimistic about future revenue opportunities [46] Other Important Information - As of May 12, 2020, KemPharm has not regained compliance with NASDAQ listing requirements, particularly concerning market capitalization and bid price [35][36] - The company plans to transition to the OTC market if delisting occurs, aiming to minimize disruption in trading [37] Q&A Session Summary Question: What is holding back discussions about the KP415 asset? - Management indicated that discussions were managed by GPC until the NDA acceptance, and Corium is now evaluating opportunities [52] Question: What processes were pursued to maximize chances for the best label? - No additional analyses were conducted; the NDA was based on existing data packages [54] Question: Can you provide estimates for the approval milestone? - The potential milestone ranges from $0 to $58 million, depending on approval outcomes [56]