Financial Data and Key Metrics Changes - For Q1 2025, the operating loss decreased to $3.7 million from $4.4 million in Q1 2024, attributed to initial net product revenues from ZUNVEL of $347,000 and recognized licensing revenue of $2.6 million from CMS [10][11] - The net loss for Q1 2025 was reported at $2 million or $0.13 per share, a decrease from a loss of $5 million or $0.87 per share in the same quarter last year, driven by increased interest income and favorable changes in derivative liabilities [11][12] - As of March 31, 2025, the company had approximately $45.5 million in unrestricted cash and cash equivalents, maintaining a debt-free balance sheet [12][13] Business Line Data and Key Metrics Changes - The commercial launch of ZUNVEL for Alzheimer's treatment has begun, with initial positive feedback and prescriptions being written shortly after launch [9][15] - Approximately 500 bottles of ZUNVEL were ordered within the first five weeks post-launch, indicating strong market demand [17] - The company has generated approximately $1 million in net sales through April 30, just four weeks into the launch [18] Market Data and Key Metrics Changes - The company is in advanced discussions for additional business development deals in new territories, expecting modest royalty revenue from the CMS deal in 2026 [5][6] - ZUNVEL became reimbursable by Medicare as of April 1, 2025, facilitating access in the long-term care segment [16] Company Strategy and Development Direction - The company aims to establish ZUNVEL as a core therapy in the long-term care market, focusing on building prescription volume and expanding its sales team gradually [9][10] - The strategy includes engaging with key plans for broader market access and monitoring prescription volume trends to support future contracting efforts [20][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early commercial traction of ZUNVEL, with qualitative feedback from healthcare professionals being overwhelmingly positive [23][24] - The company anticipates that the capital raised will be sufficient to reach a positive cash flow position by year three if execution aligns with the plan [9][13] Other Important Information - The company has received patent approval for ZUNVEL, adding to its intellectual property portfolio and providing additional protection through 2044 [7][8] - Management is actively engaging in promotional strategies, including digital programs and webinars, to enhance awareness and adoption of ZUNVEL [20][48] Q&A Session Summary Question: Can you provide details on repeat prescribers and their expected evolution? - More than half of the 100 unique accounts that placed orders have already reordered, indicating initial engagement and potential for growth [32] Question: What is the length of time patients have been on therapy? - Patients have been on therapy since April 1, with some on the drug for up to six weeks, and management expects patients to remain on the drug as long as it is effective and tolerated [30] Question: What are the current prior authorization requirements for ZUNVEL? - Prior authorization requirements have been relatively simple, with many plans requiring just a checkbox confirmation rather than extensive documentation [36] Question: What is the company's strategy for contracting in the next few months? - The company is engaged in discussions with key plans and expects to see progress in contracting as they monitor initial utilization trends [39] Question: How does the company view the market beyond Medicare? - Currently, the focus is on Medicare Part D plans, with plans to pursue commercial contracts in the future as the product gains traction [42] Question: What promotional strategies are being considered for ZUNVEL? - The current focus is on maximizing impact within the nursing home setting, with plans for sampling and broader advertising strategies as the company expands into neurology [48]

Financial Data and Key Metrics Changes - For Q1 2025, the operating loss decreased to $3.7 million from $4.4 million in Q1 2024, attributed to initial net product revenues from ZUNVEL and recognized licensing revenue of $2.6 million from CMS [9][10] - The net loss for Q1 2025 was $2 million or $0.13 per share, a decrease from a loss of $5 million or $0.87 per share in the same quarter last year, driven by increased interest income and favorable changes in derivative liabilities [10][11] - As of March 31, 2025, the company had approximately $45.5 million in unrestricted cash and cash equivalents, maintaining a debt-free balance sheet [11][12] Business Line Data and Key Metrics Changes - The first quarter of 2025 marked the first recorded revenue for ZUNVEL, with initial net product revenues of $347,000 in the last two weeks of March [4][10] - The company anticipates modest royalty revenue from the CMS deal in 2026, with additional business development deals expected to generate revenues in 2026 [5][6] Market Data and Key Metrics Changes - ZUNVEL became reimbursable by Medicare as of April 1, 2025, which is critical for long-term care access [14] - Approximately 66% of top-tier long-term care targets have been engaged by the sales team, with about 1,400 unique homes reached [15] Company Strategy and Development Direction - The company aims to establish ZUNVEL as a core therapy in the long-term care segment, focusing on building a prescription base with gerontology groups [8][19] - The management is optimistic about the commercial launch and plans to continue expanding access and awareness in the coming months [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early uptake of ZUNVEL, noting positive feedback from healthcare professionals and a strong demand for the product [14][21] - The company is focused on executing its strategic priorities and believes it can achieve a positive cash flow position in year three if it executes according to plan [8][12] Other Important Information - The company has received multiple abstracts accepted for presentation at the upcoming AAIC meeting, indicating ongoing research and validation of ZUNVEL [8][19] - Management reiterated that they are not providing revenue guidance at this time but expect to maintain expense guidance in the range of $38 million to $42 million for 2025 [12] Q&A Session Summary Question: Can you provide details on commercial metrics and repeat prescribers? - Management indicated that more than half of the 100 unique accounts that placed orders have already reordered, showing early signs of clinical adoption [31][32] Question: What is the length of time patients have been on therapy? - Patients have been on therapy since April 1, with some on the drug for up to six weeks, and management anticipates patients may remain on the drug for life as long as it is effective and tolerated [29][30] Question: What are the prior authorization requirements for ZUNVEL? - The prior authorization process has been relatively simple, with many plans requiring minimal documentation, which is encouraging for early adoption [33][34] Question: What is the company's strategy for commercial plans beyond Medicare? - The company plans to pursue commercial contracts after establishing a foothold in Medicare and Medicaid, as the long-term care segment primarily relies on Medicare [42][43] Question: How is the company addressing potential pricing pressures? - Management does not anticipate significant impacts from recent U.S. policy developments on pricing power, as they expect consistency in the Alzheimer's category [84][86]