Axsome Therapeutics(AXSM) - 2021 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q3 2021 with approximately $115 million in cash, a decrease of about $26 million from roughly $141 million at the end of Q2 2021 [18] - R&D expenses were $13.2 million for Q3 2021, down from $14.8 million in the same period of 2020, attributed to the completion of NDA-enabling clinical trials [19] - G&A expenses increased to $20.2 million in Q3 2021 from $6.3 million in Q3 2020, primarily due to pre-commercial activities and personnel expenses [19] - The net loss for Q3 2021 was $34.9 million, or $0.93 per share, compared to a net loss of $22.9 million, or $0.61 per share, in Q3 2020 [19] Business Line Data and Key Metrics Changes - AXS-05 is under NDA review for major depressive disorder (MDD), with the FDA identifying two deficiencies related to analytical methods that need to be addressed before action can be taken [9][10] - AXS-07, an acute treatment for migraine, has an NDA accepted for review with a PDUFA target action date of April 30, 2022 [11] - AXS-12 for narcolepsy has initiated a Phase III trial, with top-line results expected in the first half of 2023 [12] - AXS-14 for fibromyalgia is in the process of NDA submission, now expected in 2023 [12] Market Data and Key Metrics Changes - The U.S. is experiencing a mental health crisis, with a global study indicating a 28% increase in depression rates in 2020 due to the COVID-19 pandemic [14] - AXS-05 is positioned to address the urgent need for new treatment options for depression, especially given the increased awareness of mental health issues [14][15] Company Strategy and Development Direction - The company is focused on advancing its late-stage CNS product candidates to improve patient lives, with a strong emphasis on the commercial launch readiness for AXS-05 and prelaunch activities for AXS-07 [9][11] - The digital-centric commercialization platform is fully implemented and ready for execution, aimed at enhancing marketing efficiency and effectiveness [15] - The company is preparing for potential launches of AXS-05 and AXS-07, targeting high-value prescribers and ensuring comprehensive patient support services [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in addressing the FDA's deficiencies and emphasized the importance of AXS-05 in the treatment landscape for MDD, particularly for patients with inadequate responses to current therapies [28][29] - The company is optimistic about the potential of AXS-05 and AXS-07 to meet significant unmet needs in their respective markets [17][29] - Management highlighted the ongoing discussions with payers and the encouraging feedback received regarding the clinical profile of AXS-05 [88] Other Important Information - The company expanded its term loan facility with Hercules Capital to $300 million, providing additional financial flexibility for anticipated commercial launches [19][20] - The company aims to ensure that patients have access to its products while capturing the value they bring to the market [88] Q&A Session Summary Question: Can you provide more details on the analytical deficiencies related to AXS-05? - Management confirmed they are actively working on addressing the deficiencies and are in communication with the FDA to understand the specifics [24][25] Question: How do you view the treatment landscape for MDD with AXS-05? - Management expressed excitement about AXS-05's potential to improve treatment outcomes for patients with MDD, particularly those who are treatment-resistant [28][29] Question: What is the status of the NDA review process and potential CRL for AXS-05? - Management indicated that the FDA has not yet issued a CRL and is awaiting the company's response to the deficiencies before making a decision [42][45] Question: What are the next steps regarding the smoking cessation program? - The company received positive pre-IND meeting guidance from the FDA and plans to proceed to a pivotal Phase II/III trial, with timing to be provided next year [50][49] Question: Can you clarify the timeline for addressing the FDA's deficiencies? - Management stated that the timeline for addressing the deficiencies is weeks to months, depending on further feedback from the FDA [52][54] Question: What is the size and strategy of the sales force for the upcoming launches? - The sales force is designed to cover over 25,000 high-value prescribers, with a focus on ensuring effective promotion of AXS-05 and AXS-07 [78][79]