SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that it will participate in a fireside chat at Citi's 2025 Global Healthcare Conference on Tuesday, December 2, 2025 at 9:45 a.m. Eastern Time. A live webcast of Acadia's fireside chat will be accessible on the company's website, acadia.com, under the investors section and an archived recording will be available on the website for approximately one month following the presentation. About Acadia Pharmaceutical. ...

ACADIA Pharmaceuticals (NasdaqGS:ACAD) 2025 Conference November 18, 2025 03:30 AM ET Company ParticipantsCatherine Owen Adams - CEOModeratorGood morning and welcome to the Jefferies 2025 Global Healthcare Conference. It is my pleasure to now introduce Catherine Owen Adams, CEO of Acadia Pharmaceuticals.Catherine Owen AdamsGood morning, ladies and gentlemen. Thank you for joining us here this morning. We are a compact but bijou audience, and I look forward to sharing more about Acadia Pharmaceuticals. Today ...

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]