Group 1 - The UBS Healthcare Conference features ACADIA Pharmaceuticals with key executives present, including the Chief Financial Officer and Chief Medical Officer [1] - The conference aims to discuss recent developments and exciting updates within the company [2]

Summary of Acadia Pharmaceuticals Conference Call Company Overview - Acadia Pharmaceuticals is a neurological and rare disease company with both commercial and development-stage products, specifically NUPLAZID for Parkinson's disease psychosis and DABU for Rett syndrome [3][4] Financial Performance - The company expects to exceed $1 billion in revenue for the first time this year [4] - Acadia is cash flow positive with over $800 million in cash and no debt [4] Product Insights NUPLAZID - NUPLAZID has been on the market for about 8-9 years and is in its mid-life cycle [6] - The company is focusing on increasing awareness and expanding its commercial footprint, including a 30% increase in its sales force planned for January [10][9] - The product experienced double-digit year-over-year revenue growth and 9% volume growth in the third quarter [8] - An intellectual property (IP) win earlier this year extends the product's patent protection through February 2038 [10] DABU - DABU has 38 territories with representatives supporting its franchise, indicating a need for increased outreach to physicians [18][19] - The company is seeing an increase in referrals, marking the highest count since 2024 [20] Market Dynamics - The company is focusing on educating both physicians and caregivers about the diseases treated by its products, particularly in the context of rare diseases like Rett syndrome [22][25] - The persistency rates for DABU are over 50% at 12 months and 45% at 18 months, indicating a stable patient base [27][29] Pipeline and R&D - Acadia's pipeline includes ACP-204, targeting Alzheimer's disease psychosis and Lewy body dementia psychosis, with a Phase II readout expected mid-next year [4][39] - The company estimates a potential revenue opportunity of $11 billion from its pipeline, despite setbacks with one of its assets [37][38] - ACP-211, a deuterated norketamine, is set to enter Phase II studies for major depressive disorder [41] Competitive Landscape - The company is aware of competitors in the market but emphasizes its unique product profiles and the unmet needs in the neurological space [48][49] - Acadia is focusing on a robust target product profile for its pipeline assets, particularly in terms of safety and dosing convenience [59] International Market Considerations - The company is exploring opportunities in Europe, noting differences in care structures compared to the U.S., particularly in Germany and France [32][33] Conclusion - Acadia Pharmaceuticals is positioned for growth with a strong financial foundation, expanding product lines, and a robust pipeline aimed at addressing significant unmet medical needs in neurological disorders [4][37]

Core Insights - Acadia Pharmaceuticals reported Q3 2025 earnings of 26 cents per share, exceeding the Zacks Consensus Estimate of 14 cents, and up from 20 cents in the same quarter last year [1][8] - Total revenues for the quarter reached $278.6 million, surpassing the Zacks Consensus Estimate of $274 million, with an 11% year-over-year increase driven by sales of Nuplazid and Daybue [3][4][8] Financial Performance - Acadia's net product revenues from Nuplazid increased by 12% year-over-year to $177.5 million, exceeding the Zacks Consensus Estimate of $173 million [7][8] - Daybue recorded net product sales of $101.1 million, also up 11% year-over-year, slightly above the Zacks Consensus Estimate of $101 million [9][8] - Research and development expenses rose by 31.8% year-over-year to $87.8 million, while selling, general and administrative expenses remained almost flat at $133.4 million [9][10] Updated Financial Outlook - Acadia revised its 2025 total revenue guidance to a range of $1.070-$1.095 billion, up from the previous range of $1.045-$1.095 billion [11] - Nuplazid sales are now expected to be between $685 million and $695 million, an increase from the prior guidance of $665 million to $690 million [11] - Daybue sales are projected to be between $385 million and $400 million, slightly adjusted from the previous range of $380 million to $405 million [11] Pipeline Developments - A regulatory filing for trofinetide to treat Rett syndrome is under review in the EU, with an expected approval in Q1 2026 [13] - The phase III COMPASS PWS study for ACP-101 did not meet its primary endpoint, leading the company to discontinue further investigation of this candidate [14][15]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Financial Performance - Net product sales from NUPLAZID and DAYBUE totaled $787.5 million for the nine months ended September 30, 2025, a 12.8% increase from $698.2 million for the same period in 2024[83]. - Net product sales for the three months ended September 30, 2025, were $278.6 million, an increase from $250.4 million in the same period of 2024, representing an 11.3% growth[102]. - Net product sales of NUPLAZID increased to $177.5 million for the three months ended September 30, 2025, up from $159.2 million in 2024, reflecting an increase of 11.5%[103]. - Net product sales of DAYBUE rose to $101.1 million for the three months ended September 30, 2025, compared to $91.2 million in 2024, marking an increase of 10.9%[103]. - For the nine months ended September 30, 2025, net product sales were $787.5 million, up from $698.2 million in 2024, representing a growth of 12.8%[108]. Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $244.0 million, compared to $202.5 million for the same period in 2024, reflecting a 20.5% increase[95]. - Total research and development expenses for the three months ended September 30, 2025, were $87.8 million, up from $66.6 million in the same period in 2024, marking a 31.7% increase[95]. - Research and development expenses increased to $87.8 million for the three months ended September 30, 2025, up from $66.6 million in 2024, a rise of 31.8%[106]. - The Phase 3 study of ACP-101 for Prader-Willi syndrome did not show statistically significant improvement, leading to the decision to discontinue further investigation[85]. - A Phase 2 study for ACP-204 targeting Alzheimer's disease psychosis was initiated in November 2023, with an additional study for Lewy Body Dementia planned[86]. - The company expects continued substantial research and development expenses as it advances its product candidates and fulfills post-marketing requirements[96]. Expenses - Selling, general and administrative expenses increased to $393.3 million for the nine months ended September 30, 2025, compared to $358.3 million in 2024, a rise of 9.8%[115]. - Selling, general and administrative expenses remained relatively flat at $133.4 million for the three months ended September 30, 2025, compared to $133.3 million in 2024[107]. - Selling, general and administrative expenses are influenced by market dynamics in the PDP and Rett syndrome markets[97]. Cash and Investments - Cash, cash equivalents, and investment securities totaled $847.0 million at September 30, 2025, an increase of $91.0 million from $756.0 million at December 31, 2024[125]. - Net cash provided by operating activities totaled $158.6 million for the nine months ended September 30, 2025, compared to $117.3 million for the same period in 2024, reflecting a 35.3% increase[125]. - Net cash provided by financing activities increased to $27.2 million for the nine months ended September 30, 2025, compared to $4.9 million for the same period in 2024, primarily due to an increase in proceeds from the exercise of employee stock options and awards[127]. - The company has not engaged in any off-balance sheet arrangements, thus avoiding material exposure to financing, liquidity, market, or credit risk[128]. - The company invests excess cash in investment-grade, interest-bearing securities, with a primary objective to preserve principal and liquidity[130]. - All investment securities have a credit rating of at least Aa3/AA- or P-1/A-1, ensuring high-quality investments[130]. - A hypothetical 10 percent change in interest rates as of September 30, 2025, would not have materially affected the fair value of the investment portfolio[130]. - The company does not expect anticipated changes in interest rates to have a material effect on its interest rate risk in future reporting periods[130]. Taxation - The company anticipates significant cash tax savings in 2025 due to changes in tax legislation affecting research cost expensing[99]. Overall Financial Position - The accumulated deficit as of September 30, 2025, was $2.1 billion, indicating substantial operating losses since inception[88].

Core Insights - Acadia Pharmaceuticals reported quarterly earnings of $0.26 per share, exceeding the Zacks Consensus Estimate of $0.14 per share, and showing an increase from $0.20 per share a year ago, resulting in an earnings surprise of +85.71% [1] - The company achieved revenues of $278.63 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 1.84% and increasing from $250.4 million year-over-year [2] - Acadia's stock has increased by approximately 19.1% since the beginning of the year, outperforming the S&P 500's gain of 15.1% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.13 on revenues of $284.97 million, and for the current fiscal year, it is $0.53 on revenues of $1.07 billion [7] - The estimate revisions trend for Acadia was favorable prior to the earnings release, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Acadia belongs, is currently in the top 40% of over 250 Zacks industries, suggesting a favorable outlook for stocks within this sector [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 $278.6 million for Q3 2025, an increase of 11% year-over-year [4][21] - Debut achieved net sales of $101.1 million, also up 11% year-over-year, attributed entirely to volume growth [21] - Nuplazid delivered net sales of $177.5 million, marking a 12% year-over-year growth, with 9% of that growth coming from volume [11][21] - R&D expenses rose to $87.8 million from $66.6 million year-over-year, primarily due to higher clinical trial expenses [21] - SG&A expenses remained flat at $133.4 million compared to the previous year [21] - The company ended the quarter with $847 million in cash, up from $762 million at the end of Q2 2025 [22] Business Line Data and Key Metrics Changes - Debut generated $101.1 million in net sales, with the highest prescription volume since its launch, reaching over 1,000 unique patients globally [5][7] - Nuplazid's net sales of $177.5 million represented the strongest sales quarter ever, with a 21% increase in referrals year-over-year [11][12] - The number of unique prescribers for Debut increased to 956, with community-based physicians accounting for 74% of new prescriptions [8][9] Market Data and Key Metrics Changes - Market penetration for Debut remains low at approximately 40% in the U.S. and 27% in community settings, indicating significant growth opportunities [9] - The U.S. PDP market represents a substantial opportunity, with around 1 million Parkinson's patients, half of whom may experience hallucinations and delusions [12][13] Company Strategy and Development Direction - The company is making strategic investments in expanding its salesforce by 30% starting in Q1 2026 to capture growth opportunities for Nuplazid [14][30] - The focus is on advancing the pipeline of novel product candidates, with recent phase two and phase three trials initiated [6][16] - The company aims to achieve over $1 billion in total revenues by the end of 2025, positioning itself for continued growth into 2026 and beyond [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stability and growth trajectory driven by new sales teams for Debut, with strong patient engagement metrics [24] - The company anticipates continued growth in patient counts through Q4 2025 and into 2026, supported by the expansion of its field force [44] - Management highlighted the importance of real-world evidence in discussions with European payers to ensure the value of Debut is recognized [91] Other Important Information - The company is actively pursuing international expansion efforts, with ongoing regulatory processes in the EU for terfenatide and successful initiation of phase three studies in Japan [18][19] - The company remains committed to advancing its robust pipeline, with multiple programs progressing through key stages of development [19] Q&A Session Summary Question: How is the expanded New Plasid client-facing force organized? - The expansion focuses on both newly activated prescribers and community versus long-term care facilities, with growth seen across all channels [27][30] Question: What is the expected clinically meaningful score on the SAPS HD score for ACP204? - The company is looking for a moderate effect size of 0.4 on SAPS HD, which is deemed appropriate for the patient population [33][36] Question: How will the company ensure quick script uptake after a potential positive CHMP opinion for Debut? - The company is preparing for launch readiness in Europe, starting with Germany, and has already opened compassionate use programs in multiple countries [63][65] Question: What are the drivers behind the higher average net selling price for New Plasid? - The pricing is aligned with inflation rates, primarily due to the majority of sales being for Medicare-based patients [58][60] Question: Why is now the right time to add to the field force for New Plasid? - The decision is based on observed momentum in referrals and the need to capitalize on new prescribers outside the core target base [80][82]

Financial Performance - Total revenue for Q3 2025 reached $278.6 million, an 11% increase year-over-year compared to $250.4 million in Q3 2024[31] - NUPLAZID net sales in Q3 2025 were $177.5 million, a 12% increase year-over-year from $159.2 million in Q3 2024[31] - DAYBUE net sales in Q3 2025 hit a record $101.1 million, an 11% increase year-over-year compared to $91.2 million in Q3 2024[31, 13] - The company's EPS (diluted) increased by 110% to $0.42 in Q3 2025, compared to $0.20 in Q3 2024[31] - The company updated its full-year 2025 revenue guidance to $1.07 to $1.095 billion[32] Commercial Updates - NUPLAZID referrals grew by 21% year-over-year[17] - New prescriptions for NUPLAZID increased by 23% year-over-year[19] - 74% of new prescriptions (NBRx) for DAYBUE came from community physicians in Q3[16, 15] - Over 1,006 patients have been treated with DAYBUE globally[14] Research and Development - A Phase 2 study of ACP-204 for Lewy Body Dementia Psychosis was initiated[10, 27] - A Phase 3 trial of trofinetide for Rett syndrome in Japan was initiated[10, 27]

Financial Performance - Total revenues for Q3 2025 were $278.6 million, an 11% increase year-over-year[1] - NUPLAZID® net product sales reached $177.5 million, up 12% from $159.2 million in Q3 2024, driven by 9% volume growth[4] - DAYBUE® net product sales were $101.1 million, an 11% increase compared to $91.2 million in Q3 2024, attributed to growth in unit sales[6] - Net income for Q3 2025 was $71.8 million, or $0.42 per diluted share, compared to $32.8 million, or $0.20 per share, in Q3 2024[9] Revenue Guidance - The company raised its 2025 total revenue guidance to a range of $1.070 to $1.095 billion, up from the previous range of $1.045 to $1.095 billion[12] - NUPLAZID net product sales guidance for 2025 is now $685 to $695 million, increased from $665 to $690 million[12] - DAYBUE net product sales guidance for 2025 is updated to $385 to $400 million, compared to the prior range of $380 to $405 million[12] Research and Development - The company initiated a Phase 2 study of ACP-204 for Lewy Body Dementia Psychosis and a Phase 3 trial of trofinetide for Rett syndrome in Japan[5] - Research and development expenses for Q3 2025 were $87.8 million, up from $66.6 million in Q3 2024, primarily due to increased clinical trial costs[7] Assets and Liabilities - Total assets increased to $1,330,771 million as of September 30, 2025, up from $1,187,756 million on December 31, 2024, representing a growth of approximately 12.0%[22] - Total current assets reached $1,076,422 million, up from $938,318 million, indicating an increase of around 14.8%[22] - Total liabilities decreased to $413,499 million from $454,963 million, showing a reduction of approximately 9.1%[22] - Total stockholders' equity increased to $917,272 million, compared to $732,793 million, representing a growth of about 25.2%[22] Cash and Investments - Cash, cash equivalents, and investment securities totaled $847.0 million as of September 30, 2025, up from $756.0 million at the end of 2024[10] - Cash, cash equivalents, and investment securities rose to $847,019 million, compared to $755,993 million, reflecting an increase of about 12.0%[22] Inventory and Receivables - Accounts receivable, net increased to $115,850 million from $98,739 million, marking a growth of approximately 17.3%[22] - Inventory levels rose to $29,097 million from $21,949 million, reflecting an increase of approximately 32.5%[22] - Long-term inventory increased to $76,888 million from $69,741 million, reflecting a growth of about 10.3%[22] Other Financial Metrics - Accrued liabilities decreased to $334,837 million from $378,678 million, indicating a decline of about 11.6%[22] - Operating lease right-of-use assets increased to $49,673 million from $46,571 million, showing a growth of approximately 4.5%[22]

Core Viewpoint - Wall Street anticipates a year-over-year decline in earnings for Acadia Pharmaceuticals despite higher revenues, with actual results being crucial for stock price movement [1][2]. Financial Expectations - Acadia is expected to report quarterly earnings of $0.14 per share, reflecting a -30% change year-over-year, while revenues are projected at $273.59 million, an increase of 9.3% from the previous year [3]. - The consensus EPS estimate has been revised 1.77% higher in the last 30 days, indicating a reassessment by analysts [4]. Earnings Surprise Prediction - The Zacks Earnings ESP model shows that Acadia's Most Accurate Estimate is lower than the consensus estimate, resulting in an Earnings ESP of -19.33%, suggesting bearish sentiment among analysts [12]. - Despite the negative Earnings ESP, Acadia holds a Zacks Rank of 2, complicating predictions of an earnings beat [12]. Historical Performance - In the last reported quarter, Acadia exceeded expectations by delivering earnings of $0.16 per share against an expected $0.14, resulting in a surprise of +14.29% [13]. - Over the past four quarters, Acadia has beaten consensus EPS estimates three times [14]. Industry Context - In the broader Zacks Medical - Biomedical and Genetics industry, Amgen is expected to report earnings of $5 per share, indicating a -10.4% year-over-year change, with revenues projected at $8.94 billion, up 5.2% [18][19]. - Amgen's consensus EPS estimate has been revised down by 0.9% in the last 30 days, leading to an Earnings ESP of -1.25% and a Zacks Rank of 3, making predictions of an earnings beat challenging [19][20].