Core Viewpoint - Acadia Pharmaceuticals reported strong first-quarter 2025 earnings, exceeding expectations with total revenues driven by its marketed products, Nuplazid and Daybue [1][3][4] Financial Performance - Acadia's Q1 2025 earnings were 11 cents per share, beating the Zacks Consensus Estimate of 10 cents, and up from 10 cents in the same quarter last year [1] - Total revenues reached $244.3 million, surpassing the Zacks Consensus Estimate of $241 million, marking a 19% year-over-year increase [1][3] - Nuplazid revenues increased by 23% year over year to $159.7 million, exceeding the Zacks Consensus Estimate of $153.8 million [3] - Daybue generated net product sales of $84.6 million, an 11% year-over-year increase, although it fell short of the Zacks Consensus Estimate of $89.6 million [4] Expenses - Research and development (R&D) expenses rose to $78.3 million, a 31% increase year over year, primarily due to costs from clinical-stage programs [6] - Selling, general and administrative (SG&A) expenses were $126.4 million, up 17% year over year, attributed to increased marketing costs for Nuplazid and expansion efforts for Daybue [6] Cash Position - As of March 31, 2025, Acadia had cash, cash equivalents, and investments totaling $681.6 million, down from $756 million as of December 31, 2024 [7] Financial Outlook - Acadia expects total revenues from U.S. sales of its products to be between $1.030 billion and $1.095 billion for 2025, with Nuplazid sales projected at $650 million to $690 million and Daybue sales between $380 million and $405 million [8] - R&D expenses for 2025 are now projected to be between $330 million and $350 million, up from the previous range of $310 million to $330 million, while SG&A expenses are expected to be between $535 million and $565 million [9] Product Updates - Nuplazid is approved for treating hallucinations and delusions associated with Parkinson's disease psychosis, while Daybue is the first FDA-approved treatment for Rett syndrome, launched in April 2023 [2] - A regulatory filing for Daybue in the EU is under review, with approval expected in Q1 2026 [12] - Acadia is seeing favorable enrollment trends in the phase III COMPASS PWS study for ACP-101, with top-line results expected in early Q4 2025 [13] - The company plans to complete enrollment in the phase II RADIANT study of ACP-204 for Alzheimer's disease psychosis by Q1 2026, with top-line data anticipated in mid-2026 [14] - Acadia and Saniona completed cohorts in the phase I study of ACP-711, which showed a strong safety profile, and are focusing on essential tremor as the lead indication [15][16]

Financial Performance - Net product sales for the three months ended March 31, 2025, were $244.3 million, an increase of 18.6% compared to $205.8 million for the same period in 2024[101]. - Net product sales of NUPLAZID increased to $159.7 million for the three months ended March 31, 2025, up from $129.9 million in 2024, reflecting a growth of 22.9%[102]. - Net product sales of DAYBUE reached $84.6 million for the three months ended March 31, 2025, compared to $75.9 million in 2024, marking an increase of 11.6%[102]. - Cost of product sales for the three months ended March 31, 2025, was $20.4 million, approximately 8% of net product sales, compared to $23.0 million or 11% for the same period in 2024[104]. Research and Development - Total research and development expenses for the three months ended March 31, 2025, were $78.3 million, compared to $59.7 million in 2024, representing a 31.1% increase[95]. - The company initiated a Phase 3 study for ACP-101 in November 2023, targeting hyperphagia in Prader-Willi syndrome[85]. - A Phase 2 study for ACP-204 was also initiated in November 2023, focusing on Alzheimer's disease psychosis, with plans for an additional study in Lewy Body Dementia with Psychosis in Q3 2025[86]. - The company expects substantial ongoing research and development expenses as it conducts post-marketing studies and advances early-stage product candidates[96]. - Research and development expenses increased to $78.3 million for the three months ended March 31, 2025, from $59.7 million in the same period of 2024[107]. Operating Expenses - Selling, general and administrative expenses rose to $126.4 million for the three months ended March 31, 2025, compared to $108.0 million in the same period of 2024[108]. Cash Flow and Financing - Cash, cash equivalents, and investment securities decreased to $681.6 million at March 31, 2025, from $756.0 million at December 31, 2024, a decrease of $74.4 million[119]. - Net cash provided by operating activities totaled $20.3 million for the three months ended March 31, 2025, down from $29.1 million in the same period of 2024[119]. - Net cash used in investing activities increased to $124.0 million for the three months ended March 31, 2025, compared to $14.0 million in the same period of 2024[120]. - The company anticipates cash used in operations will fluctuate based on ongoing and planned commercial activities and development activities for various product candidates[109]. - The company may require additional financing in the future, influenced by factors such as the costs of acquiring product candidates and the scope of research and development programs[110]. Regulatory and Market Considerations - The FDA approved DAYBUE in March 2023, with the product launched in the U.S. in April 2023, and Health Canada granted marketing authorization in October 2024[90]. - The company anticipates fluctuations in operating results due to various factors, including geopolitical developments and market dynamics[100]. - The company expects to finish selling zero cost inventories of DAYBUE in 2025, with future cost of product sales estimated to be in the mid-single to high-single digit percentage range[106]. - The company expects to receive its first invoice for rebates under the Inflation Reduction Act of 2022 from Medicare Part D unit sales in 2025[118].

Core Viewpoint - ACADIA Pharmaceuticals is discussing its Q1 2025 financial results and providing updates on its commercial and research activities [3]. Group 1: Company Overview - The conference call is led by Al Kildani, Senior Vice President of Investor Relations and Corporate Communications, with participation from key executives including the CEO, COO, and CFO [2][3]. - The agenda includes opening remarks from the CEO, a discussion on the commercial brand debut in New Plaza by the COO, an update on pipeline programs by the Head of R&D, and a financial review by the CFO [3]. Group 2: Financial Highlights - Financial results for Q1 2025 will be reviewed, highlighting the company's performance and any significant changes compared to previous quarters [3].

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 - 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]

MAY 7, 2025 First Quarter 2025 Earnings Call Call Agenda | Welcome | Al Kildani Senior Vice President, Investor Relations and Corporate Communications | | --- | --- | | CEO Opening Remarks | Catherine Owen Adams Chief Executive Officer | | Commercial Update | Tom Garner Executive Vice President, Chief Commercial Officer | | R&D Update | Elizabeth H.Z. Thompson Executive Vice President, Head of Research and Development | | Financial Update | Mark Schneyer Executive Vice President, Chief Financial Officer | | ...

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]

The first-quarter earnings season for the Medical sector will be in full swing this week as several drugmakers are slated to report their earnings results. The sector mainly comprises pharma/biotech and medical device companies. Most pharma bigwigs have already reported their first-quarter earnings results. Among the large caps, J&J Merck, Bristol Myers, Novartis and Amgen have beaten both their first-quarter earnings and sales estimates, while Pfizer, Eli Lilly, Sanofi and Biogen reported mixed first-quart ...

Acadia Pharmaceuticals (ACAD) shares ended the last trading session 6.1% higher at $14.96. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 18% loss over the past four weeks.The rise in share price came after President Trump announced a 90-day pause on his sweeping tariffs against non-retaliating countries.This drugmaker is expected to post quarterly earnings of $0.05 per share in its upcoming report, which represen ...

A month has gone by since the last earnings report for Acadia Pharmaceuticals (ACAD) . Shares have lost about 11.1% in that time frame, underperforming the S&P 500.Will the recent negative trend continue leading up to its next earnings release, or is Acadia due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers.How Have Estimates Been Moving Since Then?It t ...