Financial Data and Key Metrics Changes - Total revenue for the second quarter was $264.6 million, representing a 9% year-over-year increase [6][28] - Debut net product sales were $96.1 million, up 14% year-over-year, with a 12% increase in volume [28] - NUPLAZID net product sales were $168.5 million, up 7% year-over-year, with 5% of that growth attributable to volume [29] - R&D expenses increased to $78 million from $76.2 million year-over-year, while SG&A expenses rose to $133.5 million from $117.1 million [29] - Cash balance at the end of the quarter was $762 million, up from $681.6 million at the end of Q1 [30] Business Line Data and Key Metrics Changes - Dayview sales were $96.1 million, with 987 unique patients receiving paid shipments, an increase from 954 in Q1 [9][10] - NUPLAZID saw a 17% year-over-year increase in referrals, with the highest number of new Puzzet bottles shipped since launch [16][17] Market Data and Key Metrics Changes - The proportion of new referrals from non-Center of Excellence (COE) accounts grew to about 75% of overall referrals, up from two-thirds the previous quarter [43] - The number of healthcare providers writing prescriptions for Debut increased to 900, with a significant portion coming from community settings [12][43] Company Strategy and Development Direction - The company is focused on accelerating the commercial trajectory of Debut and sustaining long-term growth for NUPLAZID [32] - Plans to initiate seven Phase II or Phase III studies over 2025 and 2026, with five data readouts expected between 2025 and 2027 [20][21] - The company aims to expand globally and reach more patients in need, with a strong emphasis on community engagement and patient support [7][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's performance and raised the low end of NUPLAZID's revenue guidance for the year to between $665 million and $690 million [30] - The company anticipates sustained growth through the second half of the year, driven by strong execution and ongoing direct-to-consumer campaigns [16][17] Other Important Information - The company hosted its first R&D Day, showcasing nine programs in development and highlighting the potential of new molecules [8][19] - Management noted recent litigation wins that enforce intellectual property for Neuclazid, reinforcing long-term strategy [7] Q&A Session Summary Question: Can you provide details on ACP101's top-line approach and key risks? - Management indicated that the focus will be on the primary endpoint and key safety and tolerability overview in the top-line announcement, with ongoing monitoring of trial conduct [34][35] Question: What percentage of new patients for Debut came from community settings? - Approximately 75% of referrals came from non-COE accounts, indicating successful penetration into the community [43] Question: How is the growth trajectory for Debut expected to evolve? - The company expects continued acceleration in new patient starts, supported by the new customer model and a stable base of persistent patients [49] Question: What are the key drivers for NUPLAZID's growth? - Growth is driven by increased referrals and ongoing direct-to-consumer campaigns, with strong performance across all channels [68] Question: What is the outlook for 2026 regarding growth for both brands? - The company anticipates continued growth for both Debut and NUPLAZID, leveraging recent momentum and expanding market opportunities [100][102]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $264.6 million, representing a 9% year-over-year increase [5][27] - Debut net product sales were $96.1 million, up 14% year-over-year, with a gross to net adjustment of 23.3% [27] - NUPLAZID net product sales were $168.5 million, up 7% year-over-year, with a gross to net adjustment of 24.6% [27][28] - R&D expenses increased to $78 million from $76.2 million in the previous year, while SG&A expenses rose to $133.5 million from $117.1 million [28] Business Line Data and Key Metrics Changes - Debut saw a patient base increase to 987 unique patients, up from 954 in Q1 2025 and 920 in Q4 2024, indicating strong growth in new patient starts and persistency [9][10] - NUPLAZID referrals increased by 17% year-over-year, with both referrals and new prescriptions rising sequentially from Q1 to Q2 [15][16] Market Data and Key Metrics Changes - The community setting accounted for approximately three-quarters of new referrals for Debut, indicating successful penetration beyond centers of excellence [41] - The company is expanding its reach in the EU, with named patient supply available in multiple countries [13] Company Strategy and Development Direction - The company is focused on accelerating the commercial trajectory of Debut and sustaining long-term growth for NUPLAZID, while advancing a deep pipeline through rigorous clinical development [31] - The company raised the low end of its NUPLAZID guidance for the year, reflecting confidence in business performance [29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued growth of Debut and NUPLAZID, supported by direct-to-consumer campaigns and field execution [5][15] - The company anticipates sustained growth through the second half of the year and beyond, with several key milestones in the pipeline [16][19] Other Important Information - The company hosted its first R&D Day, showcasing nine programs in development and five Phase II or Phase III data readouts expected through 2027 [7][19] - The company is progressing through the review process with EMA for trofinetide, with a decision expected in 2026 [21] Q&A Session Summary Question: About ACP101's top line approach and key risks - Management indicated that the focus will be on the primary endpoint and key safety and tolerability overview in the top line announcement, with ongoing monitoring of assessment variability [33][34] Question: Momentum in Debut and community setting penetration - Management reported that approximately three-quarters of new referrals came from non-center of excellence accounts, indicating successful penetration [41] Question: Discontinuations for Debut and inventory changes - Discontinuations remained below 10%, reflecting a stable patient base, and there were no significant inventory changes reported [73][74] Question: Growth perspective for 2026 - Management expects continued growth for both Debut and NUPLAZID, driven by new field force models and ongoing campaigns [96][100]

Financial Performance - Total revenue for Q2 2025 reached $264.6 million, a 9% increase year-over-year compared to $242.0 million in Q2 2024[10, 41] - NUPLAZID net sales in Q2 2025 were $168.5 million, up 7% year-over-year from $157.4 million in Q2 2024[10, 41] - DAYBUE net sales in Q2 2025 amounted to $96.1 million, reflecting a 14% increase compared to $84.6 million in Q2 2024[10, 15, 41] - The company's cash and investments balance stands at $762.0 million[41] - The company updates the full year 2025 total revenue guidance to $1.045 to $1.095 billion[44] DAYBUE Updates - 987 unique patients in the U S received DAYBUE in Q2, an increase from 954 in Q1[16] - More than 50% of patients persistency at 12 months and above 45% at 18 months[16] - 70% of active patients have been on therapy for 12 months or longer[16] NUPLAZID Updates - Referrals for NUPLAZID increased by 17% year-over-year[23] - Traffic to NUPLAZID com increased 17 times year-over-year[23] Research and Development - Top-line results from the COMPASS PWS Phase 3 study of ACP-101 are expected in early Q4 2025[11, 35] - The company anticipates filing an NDA for ACP-101 in Q1 2026, assuming positive data from the Phase 3 trial[35] - Phase 2 initiation of ACP-204 in Lewy Body Dementia Psychosis is expected in 3Q25[32]

- Second quarter total revenues of $264.6 million, up 9% year-over-year - Second quarter NUPLAZID® (pimavanserin) net product sales of $168.5 million, up 7% year-over-year - Second quarter DAYBUE ® (trofinetide) net product sales of $96.1 million, up 14% year-over-year - Raising low end of NUPLAZID net product sales guidance range to $665 to $690 million; reiterating all other prior 2025 guidance - Top-line results expected for COMPASS PWS Phase 3 study of ACP-101 in Prader Willi Syndrome in early Q4 2025 S ...

Core Viewpoint - Genmab A/S Sponsored ADR (GMAB) is currently positioned as a more attractive investment compared to Acadia Pharmaceuticals (ACAD) based on valuation metrics and earnings outlook [1][7]. Valuation Metrics - GMAB has a forward P/E ratio of 13.76, significantly lower than ACAD's forward P/E of 48.72, indicating GMAB is potentially undervalued [5]. - The PEG ratio for GMAB is 6.58, while ACAD's PEG ratio is slightly higher at 6.63, suggesting GMAB offers better value relative to its expected earnings growth [5]. - GMAB's P/B ratio stands at 2.62, compared to ACAD's P/B of 5.21, further supporting GMAB's valuation advantage [6]. Earnings Outlook - GMAB holds a Zacks Rank of 1 (Strong Buy), reflecting a positive earnings estimate revision trend, while ACAD has a Zacks Rank of 3 (Hold), indicating a less favorable earnings outlook [3][7]. - The solid earnings outlook for GMAB enhances its attractiveness as a value investment compared to ACAD [7].

Core Viewpoint - Acadia Pharmaceuticals is anticipated to report a year-over-year decline in earnings despite an increase in revenues for the quarter ended June 2025, with the actual results being crucial for its near-term stock price movement [1][2]. Financial Expectations - The consensus estimate for Acadia's quarterly earnings is $0.14 per share, reflecting a year-over-year decrease of 30%. Revenues are projected to be $260.28 million, representing a 7.6% increase from the previous year [3]. - The consensus EPS estimate has been revised down by 1.59% over the last 30 days, indicating a reassessment by analysts [4]. Earnings Surprise Potential - Acadia's Most Accurate Estimate is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +17.43%, suggesting a bullish outlook from analysts [12]. - The stock holds a Zacks Rank of 3, indicating a likelihood of beating the consensus EPS estimate [12]. Historical Performance - In the last reported quarter, Acadia was expected to post earnings of $0.10 per share but exceeded this with earnings of $0.11, achieving a surprise of +10.00% [13]. - Over the past four quarters, Acadia has surpassed consensus EPS estimates three times [14]. Industry Context - In the Zacks Medical - Biomedical and Genetics industry, TG Therapeutics is expected to report earnings of $0.32 per share for the same quarter, indicating a year-over-year increase of 700%, with revenues projected at $136.04 million, up 85.2% from the previous year [18][19].

Company Overview - ACADIA Pharmaceuticals (ACAD) is a commercial-stage biopharmaceutical company focused on neurological and rare diseases [1] - The company's portfolio includes two commercial drugs, with NUPLAZID specifically targeting positive symptoms in Parkinson's disease [1] Industry Insights - The healthcare sector is complex, requiring financial professionals and investors to have scientific and clinical expertise to navigate effectively [1] - There is a growing need for bridging the gap between cutting-edge science and financial strategy to uncover hidden value and assess risks accurately [1]

Core Insights - Kamada (KMDA) and Acadia Pharmaceuticals (ACAD) are being compared for their value to investors, with KMDA currently showing a stronger potential for value investors [1] Valuation Metrics - KMDA has a forward P/E ratio of 23.88, significantly lower than ACAD's forward P/E of 42.40, indicating that KMDA may be undervalued [5] - The PEG ratio for KMDA is 0.96, while ACAD's PEG ratio is 4.51, suggesting that KMDA offers better value relative to its expected earnings growth [5] - KMDA's P/B ratio stands at 1.8, compared to ACAD's P/B of 4.58, further supporting the notion that KMDA is the more attractive investment option based on valuation metrics [6] Zacks Rank and Value Grades - KMDA holds a Zacks Rank of 2 (Buy), indicating a positive earnings outlook, while ACAD has a Zacks Rank of 3 (Hold) [3] - KMDA has a Value grade of A, whereas ACAD has a Value grade of C, reinforcing the conclusion that KMDA is the superior value option at this time [6]

Summary of Acadia Pharmaceuticals (ACAD) R&D Day - June 25, 2025 Company Overview - Acadia Pharmaceuticals focuses on advancing care for patients with underserved neurological and rare diseases, guided by a mission to address high unmet needs in these areas [4][5][11] - The company has two profitable brands, NUPLAZID and Debut, which are expected to generate over $1 billion in combined revenue for the first time in 2025 [5][11] Financial Performance - NUPLAZID is projected to achieve net sales between GBP $650 million and GBP $690 million in 2025, reflecting a 7% to 13% year-over-year growth [6] - Debut is expected to generate net sales between $380 million and $405 million, indicating a 916% growth [7] - The total peak sales potential for NUPLAZID and Debut combined could reach between $1.5 billion and $2 billion [12] Pipeline and Future Growth - Acadia has a robust pipeline with nine disclosed programs, eight of which are expected to be in clinical stages by the end of the year [17] - The company anticipates five study readouts from Phase II or Phase III trials between now and the end of 2027 [17] - The pipeline includes later-stage assets like ACP101 for Prader-Willi syndrome and ACP204 for Alzheimer's disease psychosis, with top-line data expected in 2025 and 2026, respectively [8][17] Key Pipeline Assets 1. **ACP204**: A novel 5-HT2A inverse agonist targeting Alzheimer's and Lewy body dementia psychosis, with a significant unmet need as there are currently no approved therapies for these conditions [24][60] - Approximately 3 million people are affected by psychosis related to these diseases [27] - ACP204 is designed to avoid QT prolongation, allowing for higher dosing and potentially greater efficacy [30][60] 2. **ACP211**: An oral agent with potential ketamine-like efficacy for major depressive disorder (MDD) and treatment-resistant depression (TRD), aiming to minimize sedation and dissociation [62][81] - MDD affects approximately 21 million adults in the U.S., with only 9 million receiving treatment [67] - The drug is designed to provide rapid antidepressant effects without the severe side effects associated with current treatments [81] Strategic Focus - Acadia's growth strategy is anchored in precision medicine, data innovation, globalization, and patient empowerment [4] - The company aims to expand into adjacent rare disease categories, leveraging its scientific approach and internal capabilities [11] Market Opportunity - The potential market for the pipeline assets is significant, with an estimated combined peak sales potential of up to $12 billion if all five pipeline assets succeed [12][13] - Acadia believes that the current market undervalues its clinical programs, and it is committed to delivering data and executing its strategy to unlock this potential [13] Conclusion - Acadia Pharmaceuticals is positioned for transformational growth through its innovative pipeline and strong commercial brands, addressing critical needs in neurological and rare diseases while aiming to enhance patient care and outcomes [2][4][11]

Financial Performance and Expectations - Acadia Pharmaceuticals expects to generate over $1 Billion in total U S revenues in 2025[12] - The company estimates a risk-adjusted peak sales potential of $25 Billion from its pipeline molecules[17] - The full potential peak sales for pipeline molecules is estimated at $12 Billion, assuming successful approval and commercialization[17] - Potential peak sales of current products are projected to be in the range of $15-$2 Billion[19] Pipeline Development and Strategy - Acadia Pharmaceuticals is focused on advancing care for underserved neurological and rare diseases[11] - The company has a late-stage pipeline with ACP-101 (P3-PWS) data expected in early Q4 2025 and ACP-204 (P2-ADP) data expected in mid-2026[12] - Acadia has 2 approved medicines and 9 disclosed and multiple undisclosed programs[30] - The company anticipates 7 Phase 2 or Phase 3 study starts in 2025 and 2026, and 5 Phase 2 or Phase 3 study readouts between 2025 and 2027[30] Key Programs and Indications - ACP-204 is being developed for Alzheimer's Disease Psychosis (ADP) and Lewy Body Dementia with Psychosis (LBDP), targeting approximately 3 million patients with psychosis across PDP, LBDP, and ADP in the US[45] - ACP-211 is in development for Major Depressive Disorder (MDD), a condition affecting approximately 21 million adults in the US[93, 125] - ACP-711 is being investigated for Essential Tremor (ET), which affects an estimated 7 million people or 22% of the US population[136, 171] - DAYBUE, approved for Rett syndrome, has seen >50% of patients remain on treatment at 12 months and 65% on treatment for 12+ months[271]