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 ...

Acadia Pharmaceuticals (ACAD) came out with fourth-quarter earnings of $0.17 per share, missing the Zacks Consensus Estimate of $0.19 per share. This compares to earnings of $0.28 per share a year ago. These figures are adjusted for non-recurring items. ACAD reported GAAP earnings per share of 86 cents in the quarter.  This quarterly report represents an earnings surprise of -10.53%. A quarter ago, it was expected that this drugmaker would post earnings of $0.13 per share when it actually produced earnings ...

Acadia Pharmaceuticals (ACAD) reported fourth-quarter 2024 earnings of 17 cents per share, missing the Zacks Consensus Estimate of 19 cents. The reported figure has been adjusted for the net proceeds from the one-time sale of its Rare Pediatric Disease Priority Review Voucher. ACAD reported GAAP earnings per share of 86 cents in the quarter under review.  In the year-ago quarter, the company had reported earnings of 28 cents per share. See the Zacks Earnings Calendar to stay ahead of market-making news. Aca ...

Group 1 - The biotech forum has seen significant discussions around profitable buy-write or covered call strategies on selected biotech stocks in recent months [1] - ACADIA Pharmaceuticals reported its fourth quarter results and provided initial guidance for FY2025, indicating a positive outlook for the upcoming year [2] - The company also shared an encouraging update regarding its pipeline, suggesting potential growth opportunities [2] Group 2 - The investing group, The Biotech Forum, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live discussions on trade ideas and weekly market commentary [2]

Revenue and Market Performance - Net product sales from NUPLAZID and DAYBUE totaled $957.8 million for 2024, up from $726.4 million in 2023, representing a 31.7% increase[20] - The company estimates that approximately 130,000 Parkinson's disease patients are treated with an atypical antipsychotic annually in the U.S., with NUPLAZID capturing about 20% of this market[31] - DAYBUE is the first and only drug approved for the treatment of Rett syndrome, with an estimated prevalent population of 6,000 to 9,000 patients in the U.S.[40] - The company anticipates initial revenues from managed access programs for DAYBUE in certain European Union countries in 2025[28] - The company completed the sale of a Rare Pediatric Disease Priority Review Voucher for $150 million in December 2024[41] - Substantially all of the company's revenues since May 2016 were from U.S. net product sales of NUPLAZID and DAYBUE[197] Product Development and Clinical Trials - The company plans to initiate a Phase 2 study of ACP-204 in Lewy Body Dementia with Psychosis in Q3 2025, following the initiation of a Phase 2 study for Alzheimer's disease psychosis in November 2023[23] - ACP-101 is being evaluated in a Phase 3 study for hyperphagia in Prader-Willi syndrome (PWS) with an expected enrollment completion in Q4 2025 and top-line results in H1 2026[46][47] - The Phase 3 COMPASS PWS study will involve approximately 170 participants aged 5 to 30 years, assessing the efficacy of carbetocin nasal spray 3.2 mg three times daily[46] - ACP-204 is in Phase 2 for treating hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP), with an enrollment target of approximately 318 patients[52] - The Phase 2 RADIANT study for ACP-204 is expected to complete enrollment in Q1 2026, with top-line results anticipated around mid-2026[53] - ACP-711, licensed from Saniona, is intended for essential tremor treatment, with a Phase 2 study planned for 2026 after completing Phase 1[56][59] Regulatory and Compliance - The marketing authorization application (MAA) for DAYBUE was submitted to the European Medicines Agency (EMA) in January 2025, with expected approval in Q1 2026[43] - The FDA granted marketing authorization for DAYBUE in Canada in October 2024, with first commercial sales expected by Q3 2025[42] - The company is subject to extensive regulation by governmental authorities, impacting the development, testing, and marketing of its products[82] - The FDA's review process for New Drug Applications (NDAs) can take up to 12 months for standard reviews, with potential delays due to additional information requests[85] - The company must comply with the Clinical Trials Regulation (EU) No 536/2014, which streamlines clinical trial authorizations and reporting procedures across EU Member States[110] - The company is subject to various healthcare regulations, including the federal Anti-Kickback Statute and False Claims Act, which impose significant penalties for violations[98] Intellectual Property - The company holds approximately 54 issued U.S. patents and has licensed an additional 23 patents, emphasizing the importance of intellectual property in its business strategy[69] - The company holds exclusive licenses to 8 U.S. patents related to trofinetide, with a key patent for treating Rett syndrome expiring in 2032, potentially extendable to January 2036[74] - The company has obtained six additional U.S. patents for pimavanserin, with two patents expiring in 2037 and four in 2038[73] - The company continues to file and prosecute patent applications for ACP-101, with patents expiring in 2035 and 2039[76] - The company holds two U.S. patents for ACP-204, with the composition patent expiring in 2038[78] - The company continues to prosecute patent applications worldwide for its product candidates, ensuring ongoing protection and potential market exclusivity[75] Market Access and Reimbursement - Coverage and reimbursement from third-party payors are critical for product acceptance, and inadequate coverage could diminish revenue generation[166] - The market for products is heavily influenced by access to third-party payors' drug formularies, which can lead to pricing pressures[167] - Legislative measures in the EU and UK may impose cost-containment strategies affecting pricing and reimbursement levels for new products[168] - The company may be required to compile additional data comparing the cost-effectiveness of its products to other available therapies for reimbursement in some European countries[127] Financial Condition and Future Outlook - As of December 31, 2024, the company had an accumulated deficit of approximately $2.2 billion[196] - The company expects its cash, cash equivalents, and investment securities will be sufficient to fund planned operations through and beyond the next 12 months[198] - The company has experienced significant net losses since inception and anticipates increasing expenses in the coming years[196] - The company may require additional financing in the future to fund operations, which could significantly dilute existing stockholders[199] - The company’s future capital requirements could increase significantly due to various factors, including the costs of acquiring additional product candidates[199] Operational Risks - The company faces risks related to delays, suspensions, and terminations in clinical trials, which could harm commercial prospects[190] - The company’s success depends on attracting and retaining qualified personnel, particularly in the fields of CNS disorders and rare diseases[191] - Global economic conditions, including inflation and supply chain disruptions, could adversely affect the company's financial condition and operational results[209] - A prolonged global economic downturn may increase operating costs and limit access to credit, impacting liquidity and capital raising efforts[210] Manufacturing and Supply Chain - The company has contracted with manufacturers to produce supplies of trofinetide to support the development program and for commercial sale, with the initial term of the manufacturing agreement ending in November 2027[137] - The company has licensed worldwide intellectual property rights related to pimavanserin to Acadia Pharmaceuticals GmbH, which manages the worldwide supply chain of the active pharmaceutical ingredient (API)[132] - The company outsources manufacturing activities for its products, allowing it to direct financial resources to commercial activities and ongoing development[131] - The company has contracted with Patheon Pharmaceuticals Inc. to manufacture NUPLAZID for commercial use in the United States, with the initial term of the manufacturing agreement ending in the first quarter of 2023[135] Commercial Strategy - The company aims to maximize growth of NUPLAZID by enhancing consumer activation and increasing field force efficiency, targeting a significant portion of the Parkinson's disease market[28] - The company has a commercial team focused on marketing and sales, including specialists for both NUPLAZID and DAYBUE[143][145] - The commercial success of NUPLAZID and DAYBUE is dependent on acceptance by patients, caregivers, and physicians, with no approved competitors currently available[159][163] - The label for NUPLAZID includes a "boxed" warning, which may affect prescribing patterns and perceptions of safety[162] Collaboration and Partnerships - The company has entered into a collaboration with Stoke Therapeutics for RNA-based medicines targeting severe genetic neurodevelopmental diseases, currently in various discovery stages[63] - The company relies on collaborations with third parties for product development and commercialization, which may be affected by resource allocation and strategic focus changes[215] - Conflicts in collaborations may arise, potentially delaying product development and increasing costs due to disputes over strategy and payment responsibilities[217]

Core Insights - Acadia Pharmaceuticals reported fourth-quarter 2024 earnings of 17 cents per share, missing the Zacks Consensus Estimate of 19 cents, and adjusted for a one-time sale of a Rare Pediatric Disease Priority Review Voucher [1] - Total revenues for the quarter were $259.6 million, exceeding the Zacks Consensus Estimate of $255 million, with significant contributions from its two marketed products, Nuplazid and Daybue [2][4] Financial Performance - Revenues from Nuplazid increased 13% year over year to $162.9 million, surpassing the Zacks Consensus Estimate of $160.4 million [5] - Daybue recorded net product sales of $96.7 million, up 11% year over year, also beating the Zacks Consensus Estimate of $94.4 million [6] - For the full year 2024, Acadia's total revenues reached $957.8 million, a 32% increase year over year, exceeding the Zacks Consensus Estimate of $953.2 million [9] Expense Overview - Research and development (R&D) expenses rose 51% year over year to $100.7 million, primarily due to increased costs from clinical-stage programs [7] - Selling, general and administrative (SG&A) expenses increased 17% year over year to $130.1 million, attributed to higher marketing costs for Nuplazid and Daybue [8] Future Outlook - Acadia expects total revenues from U.S. sales of its products in 2025 to range between $1.030 billion and $1.095 billion, with Nuplazid sales projected between $650 million and $690 million, and Daybue sales expected between $380 million and $405 million [10][12] - R&D expenses for 2025 are projected to be between $310 million and $330 million, while SG&A expenses are expected to be between $535 million and $565 million [12] Product Development Updates - A regulatory filing for Daybue to treat Rett syndrome in the EU is under review, with approval expected in Q1 2026 [13] - Acadia plans to enroll the last patient in the phase III COMPASS PWS study for ACP-101 in Q4 2025, with top-line data expected in H1 2026 [14] - The company anticipates initiating a mid-stage study for ACP-204 for Lewy Body dementia psychosis in Q3 2025 [15] - Acadia signed a worldwide license agreement with Saniona to develop ACP711 for essential tremor, with a mid-stage study planned for 2026 [16][17]

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]

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]