Company Performance - Acadia Pharmaceuticals reported quarterly earnings of $0.11 per share, exceeding the Zacks Consensus Estimate of $0.10 per share, and showing an increase from $0.10 per share a year ago, representing a 10% earnings surprise [1] - The company posted revenues of $244.32 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 1.23%, and up from $205.83 million year-over-year [2] - Over the last four quarters, Acadia has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] Stock Outlook - Acadia shares have declined approximately 20.8% since the beginning of the year, compared to a 4.7% decline in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is $0.18 on revenues of $262.31 million, and for the current fiscal year, it is $0.68 on revenues of $1.06 billion [7] - The estimate revisions trend for Acadia is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Acadia belongs, is currently in the top 35% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - The company reported total revenues of $244.3 million for Q1 2025, representing a 19% increase year-over-year [7][28] - Debut net product sales were $84.6 million, up 11% from the previous year, while NUPLAZID sales reached $159.7 million, reflecting a 23% increase year-over-year [8][30] - R&D expenses increased to $78.3 million from $59.7 million in Q1 2024, and SG&A expenses rose to $126.4 million from $108 million in the same period [31] Business Line Data and Key Metrics Changes - Debut sales showed a significant increase in unique patients receiving shipments, reaching an all-time high of 954, up from 920 in Q4 2024 [11][12] - NUPLAZID's growth included a 6% increase in volume, with the remainder attributed to one-time changes in gross to net [8][30] - The company expects continued growth in both brands, with a focus on expanding patient engagement and community reach [7][9] Market Data and Key Metrics Changes - The company is preparing for a strong launch of Debut in Europe, anticipating EMA approval in Q1 2026, with a substantial market opportunity for Rett syndrome patients [14][15] - The U.S. market for NUPLAZID continues to show strong momentum, with a nearly 30% increase in awareness of Parkinson's-related hallucinations and delusions since the launch of the More to Parkinson's campaign [17][18] Company Strategy and Development Direction - The company is focused on executing strategic priorities, including accelerating Debut's commercial trajectory, capitalizing on NUPLAZID's momentum, and advancing its pipeline [33][34] - The upcoming R&D Day is expected to provide insights into the company's development strategy and showcase innovations across its pipeline [24][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of Debut's growth and reiterated full-year sales guidance for both Debut and NUPLAZID [8][9] - The company is optimistic about the upcoming results from the COMPASS PWS Phase III study, with top-line results expected by Q4 2025 [19][33] Other Important Information - The company has a strong cash balance of $681.6 million as of March 31, 2025, despite a sequential decline due to significant payments made [31] - The company is actively looking for strategic transactions to expand its portfolio, particularly in areas of high unmet medical need [84] Q&A Session Summary Question: What does good 101 data look like and how does it relate to FDA discussions? - Management indicated that statistically significant results demonstrating a clinically meaningful impact on hyperphagia would be considered good data [39] Question: How should we model a European price for Debut? - Management expressed confidence in obtaining a strong EU price that reflects the value provided to the Rett community, while monitoring potential pricing risks [40][41] Question: What are the key growth drivers for NUPLAZID and Debut from Q1 to Q2? - Management highlighted that volume will drive performance, with expectations for continued patient engagement and operational improvements [48][49] Question: What is the confidence level for EMA approval for trofinetide? - Management expressed confidence in the EMA approval process, noting that they are on track with the timeline and have received no indications of issues [82] Question: How does the company view its positioning against competitors in the Prader Willi market? - Management believes there is room for multiple therapies in the Prader Willi space, emphasizing the complex needs of patients and the potential for combination therapies [95]

Financial Data and Key Metrics Changes - Acadia Pharmaceuticals reported total revenues of $244.3 million for Q1 2025, representing a 19% increase year-over-year [6][29] - R&D expenses increased to $78.3 million from $59.7 million in Q1 2024, driven by higher spending on clinical stage programs [32] - SG&A expenses rose to $126.4 million from $108 million in Q1 2024, primarily due to ongoing consumer activation campaigns for NUPLAZID and expansion of the Debut team [32] Business Line Data and Key Metrics Changes - Debut sales reached $84.6 million in Q1 2025, an 11% increase from the previous year, with a record number of unique patients receiving shipments [7][29] - NUPLAZID generated $159.7 million in revenue for the quarter, up 23% year-over-year, with 6% of this growth attributed to volume [7][31] Market Data and Key Metrics Changes - The number of unique patients receiving Debut shipments was 954, marking an all-time high for the brand [7][11] - NUPLAZID's gross price increased by over 2% year-over-year, with a gross-to-net adjustment of 24.1% for the quarter [31] Company Strategy and Development Direction - Acadia is focused on accelerating the commercial trajectory of Debut and capitalizing on the momentum of NUPLAZID while expanding its global presence [35] - The company plans to host its first R&D Day to provide insights into its development strategy and pipeline innovations [9][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of Debut's growth and reiterated full-year sales guidance for both Debut and NUPLAZID [7][35] - The timeline for the COMPASS PWS Phase III study results is now expected by the end of 2025, indicating progress in pipeline development [9][35] Other Important Information - Acadia anticipates EMA approval for Debut in Q1 2026, with a substantial market opportunity in Europe for Rett syndrome patients [14][28] - The company has received orphan drug designation for trofinetide in Japan, which may lead to priority review [28] Q&A Session Summary Question: What does good 101 data look like and how does it relate to FDA discussions? - Management indicated that statistically significant results demonstrating a clinically meaningful impact on hyperphagia would be considered good data [40] Question: How should we model a European price for Debut? - Management expressed confidence in obtaining a strong EU price that reflects the value provided to patients in the Rett community [41] Question: What are the key growth drivers for NUPLAZID and Debut from Q1 to Q2? - Management highlighted patient demand and the impact of expanded customer models as key growth drivers for both brands [44][46] Question: What are the biggest risks to the approval process for trofinetide in the EU? - Management stated confidence in the EMA approval process, noting that they are on track with the regulatory timeline [80] Question: How does Acadia view its positioning against Celeno's product for Prader Willi? - Management believes there is room for multiple therapies in the Prader Willi space, emphasizing the complexity of patient needs [95]

Financial Performance - Total Q1 revenue reached $244.3 million, a 19% increase year-over-year[10, 44] - NUPLAZID sales in Q1 were $159.7 million, up 23% year-over-year, marking the highest ever quarterly sales[11, 23, 44] - DAYBUE sales in Q1 were $84.6 million, an 11% increase compared to Q1 2024[11, 17, 44] - Net income for Q1 was $19.0 million, a 14% increase year-over-year[44] - Earnings per share (EPS) for Q1 was $0.11, a 10% increase year-over-year[44] Product Updates - DAYBUE saw 954 unique patients receiving the therapy in Q1[18] - DAYBUE discontinuations decreased by 35% compared to Q4 2024 and 66% compared to Q1 2024[18] - 65% of active DAYBUE patients have been on therapy for 12 months or longer, with persistency rates above 50% at 12 months[18] Research and Development - Topline results from the COMPASS PWS Phase 3 trial with ACP-101 are now expected in early Q4 2025[12, 29] - The last patient-in for the COMPASS PWS Phase 3 trial is now expected in Q2 2025[29] - A Phase 2 study of ACP-204 in Lewy Body Dementia Psychosis (LBDP) is on track to initiate in Q3 2025[37] - Last patient-in for the Phase 2 study of ACP-204 in Alzheimer's Disease Psychosis (ADP) is expected in Q1 2026, with topline results expected mid-2026[38] Financial Guidance - The company anticipates total revenue between $1.03 billion and $1.095 billion for FY 2025[45] - NUPLAZID net sales are projected to be between $650 million and $690 million for FY 2025[45] - DAYBUE net sales are projected to be between $380 million and $405 million for FY 2025[45] - R&D expense is expected to be between $330 million and $350 million for FY 2025[45] - SG&A expense is expected to be between $535 million and $565 million for FY 2025[45]

Financial Performance - Total revenues for the first quarter of 2025 were $244.3 million, representing a 19% increase year-over-year[1] - NUPLAZID® net product sales reached $159.7 million, up 23% compared to $129.9 million in the first quarter of 2024[6] - DAYBUE® net product sales were $84.6 million, an 11% increase from $75.9 million in the same quarter last year[7] - Net income for the first quarter of 2025 was $19.0 million, or $0.11 per share, compared to $16.6 million, or $0.10 per share, for the same period in 2024[10] Revenue Guidance - The company expects full year 2025 revenue guidance of $1.03 to $1.095 billion, with NUPLAZID net sales projected between $650 to $690 million and DAYBUE net sales between $380 to $405 million[13] Expenses - Research and development expenses increased to $78.3 million from $59.7 million in the first quarter of 2024, primarily due to costs from clinical stage programs[8] - Selling, general and administrative expenses rose to $126.4 million from $108.0 million in the same period last year, driven by costs related to the consumer activation program for NUPLAZID[9] Patient Metrics - The company achieved a record high of 954 unique patients receiving DAYBUE shipments in the first quarter[5] Future Plans - Acadia plans to submit a New Drug Application for ACP-101 in the first quarter of 2026, pending positive results from the COMPASS PWS Phase 3 study expected in early Q4 2025[5] Cash Position - Cash, cash equivalents, and investment securities totaled $681.6 million as of March 31, 2025, down from $756.0 million at the end of 2024[11]

Core Insights - The Medical sector is experiencing a robust first-quarter earnings season, with several drugmakers reporting results, and large caps like J&J, Merck, and Amgen exceeding earnings and sales estimates [1][2] - Overall, first-quarter earnings for the Medical sector are projected to rise by 40%, with revenues expected to increase by 8.3% [3] Earnings Performance - As of April 30, 45% of Medical sector companies, representing approximately 57.9% of the sector's market capitalization, have reported earnings, with 66.7% beating both earnings and revenue estimates [2] - Year-over-year earnings growth for the sector is reported at 60.5%, while revenues have increased by 7.8% [2] Company Highlights - **Novo Nordisk**: Expected to report earnings of 92 cents per share and revenues of $11.33 billion, with strong sales anticipated from diabetes and obesity care products [6][7] - **Pacira BioSciences**: Projected earnings of 57 cents per share and revenues of $174.96 million, driven by sales of its pain-management product Exparel [8][9] - **Ultragenyx Pharmaceuticals**: Expected to report a loss of $1.54 per share and revenues of $141.99 million, with growth driven by its lead drug Crysvita [10][11] - **Acadia Pharmaceuticals**: Anticipated earnings of 6 cents per share and revenues of $241.74 million, primarily from sales of Nuplazid for Parkinson's disease psychosis [12][13] - **Denali Therapeutics**: Expected loss of 71 cents per share and revenues of $8.3 million, with updates on pipeline programs anticipated during the earnings report [17][18] Earnings Surprise Potential - The Earnings ESP methodology indicates that stocks with a positive Earnings ESP and a Zacks Rank of 1, 2, or 3 have a high chance of delivering earnings surprises, with a success rate of up to 70% [4][5]

Company Overview - Acadia Pharmaceuticals (ACAD) shares increased by 6.1% to $14.96, following a significant trading volume, contrasting with an 18% decline over the past four weeks [1] - The company is expected to report quarterly earnings of $0.05 per share, reflecting a 50% decrease year-over-year, while revenues are projected to be $241.58 million, marking a 17.4% increase from the previous year [2] Earnings Estimates and Trends - The consensus EPS estimate for Acadia has remained stable over the last 30 days, indicating that stock price movements may not sustain without changes in earnings estimate revisions [3] - The stock currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook [3] Industry Comparison - Acadia operates within the Zacks Medical - Biomedical and Genetics industry, where Kiniksa Pharmaceuticals (KNSA) also resides, closing 2.2% higher at $19.90, despite a -9.6% return over the past month [3] - Kiniksa's consensus EPS estimate is $0.06, representing a 124% increase compared to the previous year's EPS, and it holds a Zacks Rank of 2 (Buy) [4]

Company Overview - Acadia Pharmaceuticals has experienced an 11.1% decline in share price over the past month, underperforming the S&P 500 [1] - The most recent earnings report indicates a significant downward trend in estimates, with a consensus estimate shift of -62.99% [2] Performance Metrics - Acadia holds a Growth Score of B, but has a low Momentum Score of F, while achieving a Value Score of B, placing it in the top 40% for this investment strategy [3] - The aggregate VGM Score for Acadia is B, which is relevant for investors not focused on a single strategy [3] Outlook - The overall trend for Acadia's estimates is downward, with a Zacks Rank of 3 (Hold), suggesting an expectation of in-line returns in the coming months [4] Industry Comparison - Acadia is part of the Zacks Medical - Biomedical and Genetics industry, where Halozyme Therapeutics has seen an 11.8% increase in share price over the past month [5] - Halozyme Therapeutics reported revenues of $298.01 million for the last quarter, reflecting a year-over-year growth of +29.6%, with an EPS of $1.26 compared to $0.82 a year ago [6] - For the current quarter, Halozyme is expected to report earnings of $0.98 per share, indicating a year-over-year change of +24.1% [6] - Halozyme also holds a Zacks Rank of 3 (Hold) and has a VGM Score of B [7]

Company Performance - Acadia Pharmaceuticals reported fourth-quarter earnings of $0.17 per share, missing the Zacks Consensus Estimate of $0.19 per share, and down from $0.28 per share a year ago [1] - The company posted GAAP earnings per share of 86 cents for the quarter [1] - The earnings surprise for this quarter was -10.53%, while the previous quarter saw a positive surprise of 53.85% with actual earnings of $0.20 per share against an expected $0.13 [2] Revenue Insights - Acadia's revenues for the quarter ended December 2024 were $259.6 million, exceeding the Zacks Consensus Estimate by 1.79%, and up from $231.04 million year-over-year [3] - The company has surpassed consensus revenue estimates three times over the last four quarters [3] Market Performance - Acadia shares have increased by approximately 3.6% since the beginning of the year, outperforming the S&P 500's gain of 1.3% [4] - The stock's immediate price movement will depend on management's commentary during the earnings call [4] Future Outlook - The current consensus EPS estimate for the upcoming quarter is $0.14 on revenues of $235.58 million, and for the current fiscal year, it is $0.76 on revenues of $1.04 billion [8] - The estimate revisions trend for Acadia is currently unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [7] Industry Context - Acadia operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 24% of over 250 Zacks industries [9] - The performance of Acadia's stock may be influenced by the overall outlook for the industry, as the top 50% of Zacks-ranked industries tend to outperform the bottom 50% by a factor of more than 2 to 1 [9]

Core Viewpoint - Acadia Pharmaceuticals reported mixed financial results for Q4 2024, with earnings per share missing estimates but total revenues exceeding expectations, driven by the performance of its products Nuplazid and Daybue [1][2][9]. Financial Performance - Acadia reported Q4 2024 earnings of 17 cents per share, below the Zacks Consensus Estimate of 19 cents, while GAAP earnings per share were 86 cents [1]. - Total revenues for Q4 2024 reached $259.6 million, surpassing the Zacks Consensus Estimate of $255 million, marking a 12% year-over-year increase [2][4]. - For the full year 2024, Acadia's total revenues were $957.8 million, a 32% increase year over year, exceeding the Zacks Consensus Estimate of $953.2 million [9]. Product Performance - Nuplazid generated revenues of $162.9 million in Q4 2024, a 13% increase year over year, outperforming the Zacks Consensus Estimate of $160.4 million [5]. - Daybue recorded net product sales of $96.7 million in Q4 2024, an 11% year-over-year increase, also beating the Zacks Consensus Estimate of $94.4 million [6]. Expenses - Research and development (R&D) expenses for Q4 2024 were $100.7 million, up 51% year over year, primarily due to increased costs from clinical-stage programs [7]. - Selling, general and administrative (SG&A) expenses were $130.1 million, a 17% increase year over year, attributed to higher marketing costs for Nuplazid and Daybue [8]. Financial Outlook - For 2025, Acadia expects total revenues from U.S. sales to be between $1.030 billion and $1.095 billion, with Nuplazid sales projected at $650 million to $690 million and Daybue sales expected to be between $380 million and $405 million [10]. - R&D expenses for 2025 are projected to be between $310 million and $330 million, while SG&A expenses are expected to range from $535 million to $565 million [12]. Regulatory and Development Updates - Acadia has a regulatory filing for Daybue in the EU under review, with approval expected in Q1 2026 [13]. - The company plans to enroll the last patient in the phase III COMPASS PWS study for ACP-101 in Q4 2025, with top-line data anticipated in H1 2026 [14]. - Acadia is also preparing to initiate a mid-stage study for ACP-204 targeting Alzheimer's disease psychosis in Q1 2026 [15]. - The company signed a license agreement with Saniona to develop ACP711 for essential tremor, with plans for a mid-stage study in 2026 [16][17].