Core Viewpoint - Acadia Pharmaceuticals' shares increased by 26.5% following a favorable ruling from the U.S. District Court regarding the patent for its lead drug, Nuplazid, which protects the company from generic competition until 2038 [1][3]. Company Performance - Nuplazid is the only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis in the U.S. [2] - In Q1 2025, Nuplazid generated $159.7 million in revenue, marking a 23% year-over-year increase driven by volume growth [3]. - Year-to-date, Acadia's shares have risen by 21.3%, contrasting with a 6.9% decline in the industry [4]. Product Portfolio - Acadia's other marketed drug, Daybue, approved for treating Rett syndrome, generated $84.6 million in revenue in Q1 2025, an 11% increase year-over-year [5]. - Daybue reached a record high of 954 unique patients receiving shipments in Q1 2025 [7]. Pipeline Developments - Acadia is awaiting EU regulatory approval for trofinetide to treat Rett syndrome, expected in Q1 2026 [8]. - The company anticipates top-line results from the phase III COMPASS PWS study of ACP-101 for Prader-Willi Syndrome in early Q4 2025, with plans to submit a regulatory application to the FDA in Q1 2026 [9]. - Enrollment for the phase II RADIANT study of ACP-204 for Alzheimer's disease psychosis is expected to be completed in Q1 2026, with top-line data anticipated in mid-2026 [10]. - Acadia and Saniona have completed the phase I study of ACP-711, which showed a strong safety profile, and are focusing on essential tremor as the lead indication [11][12].

Acadia Pharmaceuticals Conference Call Summary Company Overview - **Company**: Acadia Pharmaceuticals (ACAD) - **Event**: BofA Healthcare Conference - **Date**: May 13, 2025 Key Industry Insights - **Most Favored Nation (MFN) Executive Order**: - No immediate impact on Acadia as it currently does not sell products outside the US [3] - Plans to commercialize Debut in Europe, with regulatory approval expected in Q1 2026 [4] - Initial launch in Germany with free pricing for the first six months [4] - **Tariffs**: - Acadia does not foresee meaningful exposure to tariffs due to existing inventory in the US that can last until the mid to late 2030s [7][9] - No manufacturing facilities owned, allowing flexibility in response to future tariff changes [8] - **FDA Interactions**: - No immediate negative impacts reported; routine interactions with the FDA are proceeding as expected [17][18] Company-Specific Developments - **Debut Launch**: - Initial strong demand followed by stagnation; new Chief Commercial Officer hired to enhance commercial execution [21][22] - Field force increased by 30% to improve outreach to physicians, particularly in local pediatric neurology centers [23] - Focus on efficacy messaging and one-to-one patient interactions to improve patient retention [24][25] - New patient starts have shown a significant increase in Q1 2025, with expectations for continued growth [26][36] - **NUPLAZID**: - Awareness campaigns have led to the best quarter in five years for new patient starts [49] - Focus on educating patients and families about Parkinson's disease psychosis, with a strong emphasis on early diagnosis [50][52] - Steady growth expected as awareness increases, with a larger patient population compared to Debut [55] Pipeline Updates - **ACP-101**: - Phase 3 trial expected to complete enrollment in Q2 2025, with top-line data anticipated in early Q4 2025 [58][60] - Primary endpoint focuses on the hyperphagia questionnaire, with a safety profile similar to previous trials [61][62] - **ECP-204**: - New inverse agonist targeting 5-HT2A receptors, currently in phase 2/3 trials for Alzheimer's disease psychosis [73] - Aiming for faster onset of action and reduced QT prolongation compared to NUPLAZID [74] Additional Considerations - **Market Dynamics**: - The rare disease market is seen as having room for multiple therapies, with Acadia's products positioned to meet diverse patient needs [66][70] - The company is focused on leveraging its expertise in rare diseases and neurology for successful product launches [71] - **Future Events**: - R&D Day scheduled for June 25, 2025, to provide further updates on pipeline developments [79]

Group 1 - The article discusses the recent focus on covered call opportunities within the biotech sector, particularly in the context of ACADIA Pharmaceuticals Inc. [1] - ACADIA Pharmaceuticals has been revisited due to a significant influx of new data points since the last analysis in March, indicating ongoing developments in the company [2] - The Biotech Forum offers a model portfolio featuring 12-20 high upside biotech stocks, along with live discussions and weekly updates on market commentary and portfolio performance [2] Group 2 - The author has a beneficial long position in ACADIA Pharmaceuticals, indicating a personal investment interest in the company's stock [3] - The article emphasizes that past performance does not guarantee future results, highlighting the inherent uncertainties in investment decisions [4]

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 [1] - The quarterly report reflects an earnings surprise of 10%, with GAAP EPS reported at 86 cents [2] - The company posted revenues of $244.32 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 1.23% and increasing from $205.83 million year-over-year [3] Market Position - Acadia shares have declined approximately 20.8% since the beginning of the year, compared to a decline of 4.7% for the S&P 500 [4] - 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 [8] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Acadia belongs, is currently ranked in the top 35% of over 250 Zacks industries, indicating a favorable outlook [9] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact investor decisions [6]

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]

[Part I. Financial Information](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2025 show increased revenues and net income, with a slight decrease in total assets Condensed Consolidated Statements of Operations (Unaudited) | Financial Metric | Three Months Ended March 31, 2025 (in thousands USD) | Three Months Ended March 31, 2024 (in thousands USD) | | :--- | :--- | :--- | | **Product sales, net** | **$244,317** | **$205,831** | | Total operating expenses | $225,027 | $190,621 | | Income from operations | $19,290 | $15,210 | | **Net income** | **$18,987** | **$16,555** | | **Diluted EPS** | **$0.11** | **$0.10** | Condensed Consolidated Balance Sheets (Unaudited) | Asset/Liability Metric | March 31, 2025 (in thousands USD) | December 31, 2024 (in thousands USD) | | :--- | :--- | :--- | | Cash and cash equivalents | $217,696 | $319,589 | | Total current assets | $870,942 | $938,318 | | **Total assets** | **$1,132,364** | **$1,187,756** | | Total current liabilities | $302,530 | $394,870 | | **Total liabilities** | **$367,127** | **$454,963** | | **Total stockholders' equity** | **$765,237** | **$732,793** | Net Product Sales Breakdown (Unaudited) | Product | Three Months Ended March 31, 2025 (in thousands USD) | Three Months Ended March 31, 2024 (in thousands USD) | | :--- | :--- | :--- | | NUPLAZID | $159,721 | $129,923 | | DAYBUE | $84,596 | $75,908 | | **Total Product sales, net** | **$244,317** | **$205,831** | [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 financial performance, highlighting increased product sales, rising R&D and SG&A expenses, and sufficient liquidity [Business Overview and Strategy](index=23&type=section&id=MD%26A_Overview) The company's strategy focuses on its neuroscience and neuro-rare disease franchises, advancing pipeline candidates like ACP-101 and ACP-204 - The company's core franchises are **Neuroscience (NUPLAZID)** and **Neuro-rare diseases (DAYBUE)**[83](index=83&type=chunk) - Key pipeline candidates include **ACP-101** for Prader-Willi syndrome (Phase 3 initiated Nov 2023) and **ACP-204** for Alzheimer's disease psychosis (Phase 2 initiated Nov 2023)[85](index=85&type=chunk)[86](index=86&type=chunk) [Results of Operations](index=27&type=section&id=MD%26A_Results_of_Operations) Q1 2025 results show increased net product sales for NUPLAZID and DAYBUE, with higher R&D and SG&A expenses Comparison of Operating Results (USD millions) | Item | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Net Product Sales | $244.3 | $205.8 | +$38.5 | | - NUPLAZID | $159.7 | $129.9 | +$29.8 | | - DAYBUE | $84.6 | $75.9 | +$8.7 | | Cost of Product Sales | $20.4 | $23.0 | -$2.6 | | R&D Expenses | $78.3 | $59.7 | +$18.6 | | SG&A Expenses | $126.4 | $108.0 | +$18.4 | - The increase in R&D expenses was mainly due to increased costs from **clinical-stage programs**[107](index=107&type=chunk) - The increase in SG&A expenses was primarily driven by costs for the **NUPLAZID consumer activation program** and higher commercial operation expenses for the planned expansion of the **DAYBUE team**[108](index=108&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=MD%26A_Liquidity_and%20Capital_Resources) The company's cash, cash equivalents, and investment securities decreased due to milestone payments, but liquidity remains sufficient for future operations - Cash, cash equivalents, and investment securities totaled **$681.6 million** at March 31, 2025, down from **$756.0 million** at December 31, 2024[119](index=119&type=chunk) - The decrease in cash was largely due to payments to Neuren, including a **$50 million sales milestone** and **$48.8 million** for one-third of PRV sale proceeds[119](index=119&type=chunk) - The company expects its current funds and anticipated product sales will be **sufficient to fund planned operations** through and beyond the next 12 months[109](index=109&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on its investment portfolio, deemed immaterial by management - The primary market risk is **interest rate risk** from its portfolio of investment-grade, interest-bearing securities[124](index=124&type=chunk) - A hypothetical **10% change in interest rates** on March 31, 2025, would not have had a material effect on the fair value of the investment portfolio[124](index=124&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal controls - Management, including the CEO and CFO, concluded that **disclosure controls and procedures were effective** as of March 31, 2025[126](index=126&type=chunk) - No changes in internal control over financial reporting occurred during the last fiscal quarter that have **materially affected internal controls**[127](index=127&type=chunk) [Part II. Other Information](index=35&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company faces ongoing patent infringement lawsuits for NUPLAZID and a securities class action, with potential losses currently inestimable - The company is engaged in ongoing **patent infringement litigation** against generic manufacturers (Aurobindo, Teva, MSN, Zydus) regarding NUPLAZID, with some cases settled[60](index=60&type=chunk)[61](index=61&type=chunk)[64](index=64&type=chunk) - An appeal by MSN in one patent case is scheduled for oral argument on **June 6, 2025**, and a decision is awaited in a separate case against MSN and Aurobindo[65](index=65&type=chunk)[66](index=66&type=chunk) - The company is defending a **securities class action lawsuit** alleging violations related to its sNDA for pimavanserin, currently in expert discovery[68](index=68&type=chunk) - Due to litigation unpredictability, the company is **unable to estimate possible losses** and has not accrued amounts beyond incurred attorneys' fees[71](index=71&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) Key risks include product commercialization dependence, drug development uncertainty, regulatory hurdles, competition, IP protection, healthcare reform, and third-party reliance - The company's prospects are highly dependent on the **successful commercialization** of its two products, NUPLAZID and DAYBUE[134](index=134&type=chunk) - Drug development is a **long, expensive, and unpredictable process** with a high risk of failure[162](index=162&type=chunk) - The company faces risks from healthcare reform measures, such as the **Inflation Reduction Act (IRA)**, which could negatively impact drug pricing and profitability[238](index=238&type=chunk)[243](index=243&type=chunk) - The company relies on a limited network of **third-party manufacturers** (e.g., Patheon, Siegfried) and distributors, posing supply chain disruption risks[159](index=159&type=chunk)[210](index=210&type=chunk) - The company faces significant **litigation risk**, including patent challenges from generic drug companies and securities class action lawsuits[219](index=219&type=chunk)[296](index=296&type=chunk)

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 - 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]