Financial Data and Key Metrics Changes - For the full year 2024, total revenues grew by 23.5% year over year to $491.7 million, exceeding previous guidance [6][25] - Full year net product revenue reached $489.3 million, a 23.4% increase over 2023, driven by the successful launch of AGAMRI [6][25] - In Q4 2024, total revenues and net product revenues reached $141.8 million, an increase of 28.3% and 30% over Q4 2023, respectively [7][25] - The company ended the year with a cash position of $517.6 million and no debt, enhancing its capacity for strategic investments [8] Business Line Data and Key Metrics Changes - Firdapse's net product revenue for 2024 was $306 million, an 18.4% increase year over year [26] - AGAMRI generated $46 million in net product revenue from its launch on March 13, 2024, through year-end [26] - Fycompa's net product revenue for 2024 was $137.3 million, slightly down from $138.1 million in 2023 due to changes in gross to net deductions [26][30] Market Data and Key Metrics Changes - Firdapse has maintained 14 consecutive quarters of 15% or more growth year over year, reflecting strong market demand [9] - AGAMRI has gained traction with 93% of the top 45 DMD centers of excellence submitting enrollments [18] - VICOMPA's full year 2024 net product revenue reached $137.3 million, surpassing guidance [19] Company Strategy and Development Direction - The company is focused on a "buy and build" approach for long-term growth, actively evaluating rare disease opportunities [13] - Catalyst is building a sustainable network of out-licensing partners and seeking markets where its products can enhance access to care [14] - The company aims to navigate market and regulatory challenges while leveraging its rare disease expertise for sustained growth [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth, forecasting total revenue for 2025 to be between $545 million and $565 million [8] - The company is committed to protecting the long-term value of its franchise amid ongoing patent litigation [10] - Management highlighted the importance of patient engagement services and strong relationships with healthcare communities [8][9] Other Important Information - The company reported a GAAP net income of $163.9 million for 2024, a 130% increase year over year [29] - Non-GAAP net income for 2024 was $276.3 million, representing a 95% increase from 2023 [30] - Research and development expenses decreased significantly in 2024 due to a one-time expense in 2023 [32] Q&A Session Summary Question: Can you provide more color on new patient adds and the low discontinuation rate for Firdapse? - Management noted over 500 pipeline leads for LEMS patients, contributing about 50% to new enrollments, with a steady discontinuation rate of 15% [40][42] Question: What is the plan for replacing revenue from Fycompa in 2026? - Management remains open to orphan and differentiated products, including potential epilepsy opportunities, but is focused on the orphan space [44][45] Question: What indications are being pursued with AGAMRI? - The company is further characterizing AGAMRI for its immunosuppressive capabilities in rare diseases [52] Question: How does the company view gene therapy opportunities? - Management is cautious about gene therapy, focusing on products that are close to market and have a clear need [53][55] Question: What is the expected impact of gross to net changes for Firdapse in 2025? - The company anticipates a gross to net change of 3% to 3.5% for 2025, influenced by the Inflation Reduction Act [61] Question: What factors are expected to drive demand for AGAMRI in 2025? - Management expects steady transitions from both prednisone and Emflaza segments, with a focus on accelerating enrollments mid-year [68] Question: How well has Firdapse penetrated the LEMS market? - Management did not provide specific penetration percentages but indicated strong market presence and growth potential [108]

Financial Data and Key Metrics Changes - In Q4 2024, total revenue was $259.6 million, up 12% year-over-year. For the full year, total revenue reached $957.8 million, up 32% from the prior year [59] - DAYBUE net product sales in Q4 were $96.7 million, an 11% increase year-over-year, and full-year sales were $348.4 million, up 97% from $177.2 million in 2023 [60] - NUPLAZID net product sales in Q4 were $162.9 million, a 13% increase year-over-year, with full-year sales of $609.4 million, up 11% from $549.2 million in the prior year [61] Business Line Data and Key Metrics Changes - DAYBUE generated sales of $96.7 million in Q4, with a full-year total of $348.4 million, indicating strong growth driven by volume [12][60] - NUPLAZID achieved Q4 sales of $162.9 million, with full-year sales of $609.4 million, reflecting growth primarily from volume [35][61] Market Data and Key Metrics Changes - The company anticipates over $1 billion in revenue in the U.S. for 2025, driven by growth in both DAYBUE and NUPLAZID [8] - NUPLAZID's market share increased from 20% to 25% among patients receiving atypical antipsychotics for Parkinson's-related hallucinations and delusions [37][112] Company Strategy and Development Direction - The corporate strategy focuses on expanding neuroscience and neuro rare disease franchises, with plans to explore additional investments in rare diseases [11] - The company aims to achieve significant milestones in 2025 and 2026, including the anticipated approval of trofinetide in Europe [73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, citing strong financial results and a robust pipeline as key factors [7][8] - The company expects to see continued growth in both DAYBUE and NUPLAZID, with specific strategies to enhance market penetration and patient engagement [20][39] Other Important Information - The company plans to hold its first R&D Day on June 25, 2025, to provide more insights into its pipeline and development programs [57] - The cash balance at the end of 2024 was $756 million, significantly up from $438.9 million at the end of 2023, primarily due to operational cash flows and the sale of a priority review voucher [63] Q&A Session Summary Question: How should we think about the evolution of growth-to-net for DAYBUE and NUPLAZID? - Management indicated that DAYBUE's growth-to-net is expected to remain in the low 20% range, influenced by Medicare Part D redesign [79] - For NUPLAZID, a 300 basis points price benefit is anticipated, with growth-to-net expected to improve over the next several years [81] Question: Is there a target number of patients for DAYBUE by year-end? - Management stated that the patient base is stable, with no expected meaningful decline in patients sequentially [87] - The focus will be on expanding the reach to the 70% of the Rett population that has yet to try DAYBUE [91] Question: Can you discuss the increase in diagnosed U.S. Rett patients? - The increase in diagnosed patients is attributed to better tracking and diagnostics, with a current estimate of 5,500 to 5,800 patients [95] Question: How does ACP-711 compare with SAGE-324? - Management highlighted that ACP-711 targets GABA-Alpha-3 receptors specifically, which may reduce potential safety side effects compared to SAGE-324 [98] Question: What are the secondary endpoints for ACP-101 in Prader-Willi syndrome? - Management expressed confidence that multiple mechanisms of action will be effective in treating Prader-Willi syndrome, with ongoing trials focusing on specific endpoints [118]