Axsome Therapeutics(AXSM) - 2021 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended 2021 with approximately $87 million in cash, down from roughly $115 million at the end of Q3 2021, representing a net decrease of approximately $28 million [16] - R&D expenses for Q4 2021 were $13.8 million, a decrease from $17.4 million in Q4 2020, primarily due to the conclusion of several clinical trials [17] - G&A expenses for Q4 2021 were $18.8 million, up from $10.4 million in Q4 2020, mainly due to pre-commercial activities and increased stock compensation [18] - The net loss for Q4 2021 was $34 million, or $0.90 per share, compared to a net loss of $29.2 million, or $0.78 per share, in Q4 2020 [18] - For the full year, the net loss was $130.4 million, or $3.47 per share, compared to a net loss of $102.9 million, or $2.77 per share, in 2020 [18] Business Line Data and Key Metrics Changes - AXS-05 is undergoing NDA review for major depressive disorder (MDD) and is also being developed for Alzheimer’s Disease Agitation, with enrollment in the Phase 3 ACCORD trial progressing [9] - AXS-07, an acute treatment for migraine, has its NDA accepted for review with a PDUFA target action date of April 30, 2022 [10] - AXS-12 for narcolepsy is in the SYMPHONY Phase III trial, with top-line results expected in the first half of 2023 [10] - AXS-14 for fibromyalgia is expected to have its NDA submitted in 2023 [10] Market Data and Key Metrics Changes - The migraine market shows a 70% dissatisfaction rate with current therapies, indicating a high unmet need for new treatments [14] - The company’s commercialization strategy for AXS-07 will be strategic and highly targeted, addressing the significant dissatisfaction in the migraine treatment landscape [15] Company Strategy and Development Direction - The company is preparing for the potential launch of two investigational medicines for depression and migraine, with a focus on innovative commercialization strategies [8][12] - The Digital Centric Commercialization (DCC) platform is designed to enhance engagement with physicians and patients through technology and data analytics [15][96] - The company aims to leverage the unmet needs in the depression and migraine markets to position its products effectively [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential launch of AXS-05 and AXS-07, emphasizing the urgent need for new treatment options in depression and migraine [12][14] - The company is actively engaging with the FDA regarding the NDA reviews and is prepared to respond to any further inquiries [24][41] - Management acknowledged the resource constraints at the FDA, which may be contributing to delays in the review process [41] Other Important Information - The company expanded its term loan facility with Hercules Capital to $300 million, providing additional financial flexibility for anticipated commercial launches [18] - The proforma cash position at year-end is approximately $106 million, which is expected to fund operations into 2024 [19] Q&A Session Summary Question: Next steps with the FDA for AXS-05 - The company confirmed that they responded to two deficiencies related to the NDA and are awaiting further feedback from the FDA [24] Question: Enrollment progress for AXS-05 in Alzheimer's agitation - Enrollment is proceeding well, and the company is on track to meet guidance for reporting results in the first half of 2023 [26] Question: Unmet need and product positioning for AXS-07 - The company highlighted a 70% dissatisfaction rate with current migraine therapies, indicating a significant unmet need for AXS-07 [18] Question: Timeline for approval and launch of AXS-05 and AXS-07 - The company anticipates launching within one quarter after receiving regulatory approval for both products [45] Question: Insights on FDA delays - Management noted that resource constraints at the FDA could be contributing to the delays, but they are focused on responding promptly to the FDA's requests [41] Question: Commercial preparations and payer discussions - The company has engaged with payers since April 2021 and is encouraged by the recognition of unmet needs in MDD [66]