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]

Financial Data and Key Metrics Changes - In Q4 2024, total revenue was $259.6 million, up 12% year-over-year, while full year revenue reached $957.8 million, up 32% from the prior year [59] - DAYBUE sales in Q4 were $96.7 million, an 11% increase year-over-year, and full year sales were $348.4 million, a 97% increase compared to $177.2 million in 2023 [60] - NUPLAZID 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's gross-to-net was 18.8% for the year, with a sequential growth of 5% in volume and 1% in net price in Q4 [60] - NUPLAZID's gross-to-net for Q4 was 23.2%, with full year gross-to-net at 26.1%, indicating a balanced growth from both volume and net price [61] Market Data and Key Metrics Changes - The company anticipates U.S. net sales for DAYBUE in 2025 to be between $380 million and $405 million, with expected volume growth of 9% to 16% year-over-year [63] - NUPLAZID's 2025 net sales are projected to be in the range of $650 million to $690 million, with growth expected to be split evenly between volume and net price [68] 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 over $1 billion in annual net sales by 2025, joining a select group of biotech companies [73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of both DAYBUE and NUPLAZID, highlighting the importance of expanding the prescriber base and patient engagement [20][25] - The company plans to initiate a Phase 2 study for ACP-204 in Lewy body dementia psychosis and expects to see top-line results for ACP-101 in Prader-Willi syndrome in the first half of 2026 [74] Other Important Information - The company has submitted a marketing application for trofinetide in the EU, anticipating approval in Q1 2026 [42] - The cash balance at the end of 2024 was $756 million, significantly up from $438.9 million at the end of 2023, driven by 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 [80] - For NUPLAZID, a 300 basis points price benefit is expected in growth-to-net, with gradual increases anticipated 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 around 70% of the Rett population yet to try DAYBUE, indicating significant growth potential [91] Question: Can you discuss the increase in diagnosed U.S. Rett patients? - The increase in diagnosed patients from 5,000 to 5,800 is attributed to improved diagnostics and awareness driven by the launch of DAYBUE [95] Question: What are the secondary endpoints for ACP-101 in Prader-Willi syndrome? - Management expressed confidence that multiple mechanisms of action will be needed to treat patients in areas of unmet medical need like Prader-Willi syndrome [118]

Core Viewpoint - Acadia Pharmaceuticals reported quarterly earnings of $0.17 per share, missing the Zacks Consensus Estimate of $0.19 per share, and showing a decline from $0.28 per share a year ago, indicating an earnings surprise of -10.53% [1] Financial Performance - The company posted revenues of $259.6 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 1.79%, compared to $231.04 million in the same quarter last year [2] - Over the last four quarters, Acadia has exceeded consensus EPS estimates three times and has topped consensus revenue estimates three times as well [2] Stock 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% [3] Future Outlook - The company's earnings outlook will be crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the next 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 [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Acadia belongs, is currently ranked in the top 24% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Performance - Total net product sales for 2024 reached $957.8 million, reflecting a 32% revenue growth compared to the previous year[1] - Fourth quarter net product sales of DAYBUE™ (trofinetide) were $96.7 million, with full year sales of $348.4 million[1] - Fourth quarter net product sales of NUPLAZID® (pimavanserin) were $162.9 million, totaling $609.4 million for the full year 2024, marking an 11% increase from 2023[1][5] - Total revenues for Q4 2024 reached $259.6 million, a 12.4% increase from $231.0 million in Q4 2023[21] - Acadia reported a net income of $143.7 million for Q4 2024, or $0.86 per share, compared to a net income of $45.8 million, or $0.28 per share, in Q4 2023[9] - Net income for Q4 2024 was $143.7 million, compared to a net income of $45.8 million in Q4 2023, representing a significant increase of 213.5%[21] - Basic earnings per share for Q4 2024 were $0.86, compared to $0.28 in Q4 2023, representing a 207.1% increase[21] - The company reported a gain on the sale of a non-financial asset of $146.5 million in Q4 2024, which significantly impacted the overall financial performance[21] Expenses - Research and development expenses for Q4 2024 were $100.7 million, compared to $66.7 million in Q4 2023, while total R&D expenses for 2024 were $303.2 million[7] - Selling, general and administrative expenses for Q4 2024 were $130.1 million, up from $111.5 million in Q4 2023, with full year expenses totaling $488.4 million[8] - Research and development expenses increased to $100.7 million in Q4 2024, up from $66.7 million in Q4 2023, reflecting a 50.9% rise[21] - Total operating expenses decreased to $106.1 million in Q4 2024 from $196.1 million in Q4 2023, a reduction of 45.9%[21] Guidance and Future Plans - Full year 2025 total revenue guidance is set between $1.03 billion and $1.095 billion, with DAYBUE net sales guidance of $380 to $405 million and NUPLAZID net sales guidance of $650 to $690 million[1][18] - Acadia plans to expand its DAYBUE field force in the U.S. and build its EU commercial team in anticipation of launching trofinetide in Europe next year[2] Assets and Equity - Cash, cash equivalents, and investment securities totaled $756.0 million as of December 31, 2024, compared to $438.9 million at the end of 2023[12] - Cash, cash equivalents, and investment securities increased to $756.0 million as of December 31, 2024, compared to $438.9 million at the end of 2023, marking a 72.4% increase[23] - Total assets grew to $1.19 billion in 2024, up from $749.0 million in 2023, indicating a 58.6% increase[23] - Total stockholders' equity rose to $732.8 million in 2024, compared to $431.8 million in 2023, reflecting an increase of 69.8%[23] Liabilities - Total liabilities increased to $455.0 million in 2024 from $317.2 million in 2023, a rise of 43.5%[23] Regulatory and Market Developments - The marketing authorization application for trofinetide was submitted to the European Medicines Agency (EMA) in January 2025, with expected approval in Q1 2026[3]

Group 1 - Investors in Acadia Pharmaceuticals Inc. (ACAD) should monitor stock movements due to high implied volatility in the options market, particularly the Mar 21, 2025 $12 Put option [1] - Implied volatility indicates the market's expectation of future stock movement, suggesting potential significant price changes or upcoming events that could impact the stock [2] - Acadia Pharmaceuticals currently holds a Zacks Rank 3 (Hold) in the Medical - Biomedical and Genetics industry, which is in the top 29% of the Zacks Industry Rank [3] Group 2 - The high implied volatility for ACADIA Pharmaceuticals may indicate a developing trading opportunity, as options traders often seek to sell premium on such options to capture decay [4]

Core Viewpoint - Acadia Pharmaceuticals has submitted a marketing authorization application to the European Medicines Agency for trofinetide to treat Rett syndrome, with an expected approval in Q1 2026, potentially making it the first approved therapy for this condition in the EU [1][2]. Group 1: Product Development and Approval - Trofinetide is already approved in the U.S. under the name Daybue for treating Rett syndrome in patients aged two years and older, launched in April 2023 [2]. - The MAA for trofinetide in the EU is based on positive results from the phase III LAVENDER study, which involved 187 female patients aged 5 to 20 years [4]. - The LAVENDER study met its co-primary endpoints, showing significant improvements in the Rett Syndrome Behaviour Questionnaire total score and the Clinical Global Impression-Improvement scale score at week 12 [5]. Group 2: Market Potential and Financial Outlook - If approved, trofinetide's launch in the EU is expected to enhance Acadia's growth prospects [6]. - Acadia anticipates generating over $1 billion in combined net sales for Nuplazid and Daybue in 2025 [8]. - The company is also evaluating other pipeline candidates, including ACP-101 for Prader-Willi Syndrome and ACP-204 for Alzheimer's disease psychosis, with key data expected in 2026 [9][10]. Group 3: Stock Performance - Acadia's shares have decreased by 41.6% over the past year, compared to a 14.8% decline in the industry [3].

Core Viewpoint - Acadia Pharmaceuticals has submitted a marketing authorization application to the European Medicines Agency for trofinetide to treat Rett syndrome, with an expected approval in Q1 2026, potentially making it the first approved therapy for this condition in the EU [1][2]. Group 1: Product Development and Approval - Trofinetide is already approved in the U.S. under the name Daybue for treating Rett syndrome in patients aged two years and older, launched in April 2023 [2]. - The MAA for trofinetide in the EU is based on positive results from the phase III LAVENDER study, which involved 187 female patients aged 5 to 20 years [4]. - The LAVENDER study met its co-primary endpoints, showing significant improvements in the Rett Syndrome Behaviour Questionnaire total score and the Clinical Global Impression-Improvement scale score at week 12 [5]. Group 2: Financial Outlook and Pipeline - Acadia expects to generate over $1 billion in combined net sales for Nuplazid and Daybue in 2025 [8]. - The company is evaluating ACP-101 in the phase III COMPASS PWS study for Prader-Willi Syndrome, with top-line data expected in the first half of 2026 [8]. - Acadia is also developing ACP-204 in the phase II RADIANT study for Alzheimer's disease psychosis, with top-line data expected in mid-2026 [9].

Core Insights - Zacks Premium provides various tools for investors to enhance their stock market strategies and confidence [1][2] Zacks Style Scores - Zacks Style Scores are indicators that rate stocks based on value, growth, and momentum methodologies, helping investors identify stocks likely to outperform in the next 30 days [3][4] - Stocks are rated from A to F, with A indicating the highest potential for outperformance [4] Categories of Style Scores - **Value Score**: Focuses on identifying undervalued stocks using ratios like P/E, PEG, and Price/Sales [5] - **Growth Score**: Analyzes projected and historical earnings, sales, and cash flow to find stocks with sustainable growth [6] - **Momentum Score**: Utilizes price trends and earnings estimate changes to identify favorable investment opportunities [7] - **VGM Score**: Combines all three Style Scores to highlight stocks with attractive value, growth forecasts, and momentum [8] Zacks Rank and Style Scores - The Zacks Rank is a proprietary model that uses earnings estimate revisions to assist in portfolio building [9] - Stocks rated 1 (Strong Buy) have historically produced an average annual return of +25.41% since 1988, significantly outperforming the S&P 500 [10] - Investors are encouraged to select stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal success [12] Example Company: Acadia Pharmaceuticals - Acadia Pharmaceuticals is a biopharmaceutical company focused on CNS disorders and rare diseases [15] - Currently rated 3 (Hold) with a VGM Score of B, Acadia has a Momentum Style Score of A and has seen a 13.6% increase in shares over the past four weeks [16] - Six analysts have raised earnings estimates for fiscal 2024, with the consensus estimate increasing by $0.19 to $0.73 per share, and an average earnings surprise of 54.1% [16][17]

Licensing Agreement and Strategic Focus - Acadia Pharmaceuticals signed an exclusive worldwide license agreement with Saniona to develop and commercialize SAN711, a first-in-class GABAA-α3 positive allosteric modulator [1] - SAN711 will initially be studied for essential tremor, a neurological condition with significant unmet treatment needs, with a mid-stage study planned for 2026 [2][3] - The agreement includes an upfront payment of $28 million and potential milestone payments of up to $582 million, with tiered royalties on net sales [5][6] Financial Performance and Marketed Portfolio - Acadia's shares have declined 48.2% year-to-date, significantly underperforming the industry's 7.8% decline [4] - The company's marketed portfolio includes Nuplazid and Daybue, with Nuplazid generating $446.5 million in revenue in the first nine months of 2024, a 10% year-over-year increase [7][9] - Daybue, approved for Rett syndrome, was launched in April 2023 and contributes incremental revenue [8][9] Pipeline Development and Future Growth - Acadia is evaluating carbetocin nasal spray (ACP-101) in a phase III study for Prader-Willi syndrome and plans to submit a new drug application upon successful results [11] - The company is also developing ACP-204 for Alzheimer's disease psychosis, with a mid-stage study initiated in Q4 2023 [12] - Future approvals of pipeline candidates could diversify revenue streams and reduce reliance on Nuplazid [13] Industry Comparison and Peer Performance - Acadia currently holds a Zacks Rank 3 (Hold), while peers like Allogene Therapeutics, Pfizer, and Gilead Sciences hold a Zacks Rank 2 (Buy) [14] - Allogene Therapeutics' loss per share estimates have narrowed, with shares down 21.5% year-to-date [15] - Pfizer's earnings estimates have risen, with shares down 10.6% year-to-date, while Gilead Sciences' shares have risen 12.8% year-to-date [16][17]

Core Insights - Zacks Premium offers tools for investors to enhance their stock market engagement and confidence [1] - The Zacks Style Scores are designed to complement the Zacks Rank, aiding in stock selection based on value, growth, and momentum [2][6] Zacks Style Scores Overview - Stocks are rated A, B, C, D, or F based on their value, growth, and momentum characteristics, with higher scores indicating better performance potential [3] - The Style Scores are categorized into four types: Value Score, Growth Score, Momentum Score, and VGM Score [3][4][5] Value Score - The Value Score identifies attractive and discounted stocks using ratios like P/E, PEG, Price/Sales, and Price/Cash Flow [3] Growth Score - The Growth Score focuses on a company's financial strength and future outlook, analyzing projected and historical earnings, sales, and cash flow [4] Momentum Score - The Momentum Score helps investors capitalize on price trends, utilizing factors like one-week price change and monthly earnings estimate changes [4] VGM Score - The VGM Score combines all three Style Scores, providing a comprehensive indicator for stock selection based on value, growth, and momentum [5] Zacks Rank Integration - The Zacks Rank uses earnings estimate revisions to guide investors in portfolio creation, with 1 (Strong Buy) stocks yielding an average annual return of +25.41% since 1988 [6][7] - Investors are encouraged to select stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal success [8] Acadia Pharmaceuticals (ACAD) Analysis - Acadia Pharmaceuticals is a biopharmaceutical company focused on CNS disorders and rare diseases, currently rated 3 (Hold) with a VGM Score of B [10] - The company has seen a 21.9% increase in shares over the past four weeks, with four analysts revising earnings estimates upwards for fiscal 2024 [10][11] - The Zacks Consensus Estimate for ACAD has risen by $0.04 to $0.58 per share, with an average earnings surprise of 54.1% [11]