Core Viewpoint - Acadia Pharmaceuticals has submitted a marketing authorization application to the European Medicines Agency for trofinetide to treat Rett syndrome, with an expected approval in Q1 2026, potentially making it the first approved therapy for this condition in the EU [1][2]. Group 1: Product Development and Approval - Trofinetide is already approved in the U.S. under the name Daybue for treating Rett syndrome in patients aged two years and older, launched in April 2023 [2]. - The MAA for trofinetide in the EU is based on positive results from the phase III LAVENDER study, which involved 187 female patients aged 5 to 20 years [4]. - The LAVENDER study met its co-primary endpoints, showing significant improvements in the Rett Syndrome Behaviour Questionnaire total score and the Clinical Global Impression-Improvement scale score at week 12 [5]. Group 2: Financial Outlook and Pipeline - Acadia expects to generate over $1 billion in combined net sales for Nuplazid and Daybue in 2025 [8]. - The company is evaluating ACP-101 in the phase III COMPASS PWS study for Prader-Willi Syndrome, with top-line data expected in the first half of 2026 [8]. - Acadia is also developing ACP-204 in the phase II RADIANT study for Alzheimer's disease psychosis, with top-line data expected in mid-2026 [9].

Core Insights - Zacks Premium provides various tools for investors to enhance their stock market strategies and confidence [1][2] Zacks Style Scores - Zacks Style Scores are indicators that rate stocks based on value, growth, and momentum methodologies, helping investors identify stocks likely to outperform in the next 30 days [3][4] - Stocks are rated from A to F, with A indicating the highest potential for outperformance [4] Categories of Style Scores - **Value Score**: Focuses on identifying undervalued stocks using ratios like P/E, PEG, and Price/Sales [5] - **Growth Score**: Analyzes projected and historical earnings, sales, and cash flow to find stocks with sustainable growth [6] - **Momentum Score**: Utilizes price trends and earnings estimate changes to identify favorable investment opportunities [7] - **VGM Score**: Combines all three Style Scores to highlight stocks with attractive value, growth forecasts, and momentum [8] Zacks Rank and Style Scores - The Zacks Rank is a proprietary model that uses earnings estimate revisions to assist in portfolio building [9] - Stocks rated 1 (Strong Buy) have historically produced an average annual return of +25.41% since 1988, significantly outperforming the S&P 500 [10] - Investors are encouraged to select stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal success [12] Example Company: Acadia Pharmaceuticals - Acadia Pharmaceuticals is a biopharmaceutical company focused on CNS disorders and rare diseases [15] - Currently rated 3 (Hold) with a VGM Score of B, Acadia has a Momentum Style Score of A and has seen a 13.6% increase in shares over the past four weeks [16] - Six analysts have raised earnings estimates for fiscal 2024, with the consensus estimate increasing by $0.19 to $0.73 per share, and an average earnings surprise of 54.1% [16][17]

Licensing Agreement and Strategic Focus - Acadia Pharmaceuticals signed an exclusive worldwide license agreement with Saniona to develop and commercialize SAN711, a first-in-class GABAA-α3 positive allosteric modulator [1] - SAN711 will initially be studied for essential tremor, a neurological condition with significant unmet treatment needs, with a mid-stage study planned for 2026 [2][3] - The agreement includes an upfront payment of $28 million and potential milestone payments of up to $582 million, with tiered royalties on net sales [5][6] Financial Performance and Marketed Portfolio - Acadia's shares have declined 48.2% year-to-date, significantly underperforming the industry's 7.8% decline [4] - The company's marketed portfolio includes Nuplazid and Daybue, with Nuplazid generating $446.5 million in revenue in the first nine months of 2024, a 10% year-over-year increase [7][9] - Daybue, approved for Rett syndrome, was launched in April 2023 and contributes incremental revenue [8][9] Pipeline Development and Future Growth - Acadia is evaluating carbetocin nasal spray (ACP-101) in a phase III study for Prader-Willi syndrome and plans to submit a new drug application upon successful results [11] - The company is also developing ACP-204 for Alzheimer's disease psychosis, with a mid-stage study initiated in Q4 2023 [12] - Future approvals of pipeline candidates could diversify revenue streams and reduce reliance on Nuplazid [13] Industry Comparison and Peer Performance - Acadia currently holds a Zacks Rank 3 (Hold), while peers like Allogene Therapeutics, Pfizer, and Gilead Sciences hold a Zacks Rank 2 (Buy) [14] - Allogene Therapeutics' loss per share estimates have narrowed, with shares down 21.5% year-to-date [15] - Pfizer's earnings estimates have risen, with shares down 10.6% year-to-date, while Gilead Sciences' shares have risen 12.8% year-to-date [16][17]

Core Insights - Zacks Premium offers tools for investors to enhance their stock market engagement and confidence [1] - The Zacks Style Scores are designed to complement the Zacks Rank, aiding in stock selection based on value, growth, and momentum [2][6] Zacks Style Scores Overview - Stocks are rated A, B, C, D, or F based on their value, growth, and momentum characteristics, with higher scores indicating better performance potential [3] - The Style Scores are categorized into four types: Value Score, Growth Score, Momentum Score, and VGM Score [3][4][5] Value Score - The Value Score identifies attractive and discounted stocks using ratios like P/E, PEG, Price/Sales, and Price/Cash Flow [3] Growth Score - The Growth Score focuses on a company's financial strength and future outlook, analyzing projected and historical earnings, sales, and cash flow [4] Momentum Score - The Momentum Score helps investors capitalize on price trends, utilizing factors like one-week price change and monthly earnings estimate changes [4] VGM Score - The VGM Score combines all three Style Scores, providing a comprehensive indicator for stock selection based on value, growth, and momentum [5] Zacks Rank Integration - The Zacks Rank uses earnings estimate revisions to guide investors in portfolio creation, with 1 (Strong Buy) stocks yielding an average annual return of +25.41% since 1988 [6][7] - Investors are encouraged to select stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal success [8] Acadia Pharmaceuticals (ACAD) Analysis - Acadia Pharmaceuticals is a biopharmaceutical company focused on CNS disorders and rare diseases, currently rated 3 (Hold) with a VGM Score of B [10] - The company has seen a 21.9% increase in shares over the past four weeks, with four analysts revising earnings estimates upwards for fiscal 2024 [10][11] - The Zacks Consensus Estimate for ACAD has risen by $0.04 to $0.58 per share, with an average earnings surprise of 54.1% [11]

Group 1 - The discussion in the biotech community has focused on profitable buy-write or covered call strategies for selected biotech stocks over recent months [1] - ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) was identified as a mid-cap biopharma stock that was in the "buy zone" as of June, indicating positive sentiment towards its shares [2] - The Biotech Forum offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat for trade ideas and weekly market commentary [2] Group 2 - The analyst has a beneficial long position in ACAD shares through various financial instruments, indicating confidence in the stock's performance [3] - Seeking Alpha emphasizes that past performance does not guarantee future results and that no specific investment advice is provided [4]

Core Viewpoint - Acadia Pharmaceuticals reported a strong third-quarter performance for 2024, with earnings per share of 20 cents, surpassing estimates and showing significant revenue growth driven by its products Nuplazid and Daybue [1][3][4]. Financial Performance - Acadia's total revenues reached $250 million, exceeding the Zacks Consensus Estimate of $249 million, marking an 18% year-over-year increase [1][3]. - Revenues from Nuplazid increased by 10% year over year to $159.2 million, driven by a 7% growth in volumes, and also surpassed the Zacks Consensus Estimate of $155.6 million [4]. - Daybue generated net product sales of $91.2 million in the quarter, reflecting a 36% year-over-year increase, although it fell short of the Zacks Consensus Estimate of $93.8 million [4]. Expenses and Guidance - Research and development (R&D) expenses decreased by 58% year over year to $66.6 million, primarily due to reduced business development payments [5]. - Selling, general and administrative (SG&A) expenses rose by 36% year over year to $133.3 million, attributed to increased marketing costs for Daybue and consumer activation programs for Nuplazid [6]. - Acadia updated its 2024 financial guidance, projecting total revenue between $940 million and $960 million, with Daybue sales expected to be between $340 million and $350 million [8][9]. Cash Position and Strategic Moves - As of September 30, 2024, Acadia had cash, cash equivalents, and investments totaling $565.3 million, an increase from $500.9 million as of June 30, 2024 [7]. - The company announced a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher for $150 million, which will support its commercial operations and R&D programs [11][12].

Financial Data and Key Metrics - Total net sales for Q3 2024 were $250.4 million, up 18% YoY [49] - DAYBUE net product sales were $91.2 million in Q3, up 36% YoY and 8% sequentially [49] - NUPLAZID net product sales were $159.2 million in Q3, up 10% YoY [49] - Gross to net for NUPLAZID was 24.9% in Q3 [50] - R&D expenses decreased to $66.6 million in Q3 2024 from $157 million in Q3 2023 [51] - SG&A expenses increased to $133.3 million in Q3 2024 from $97.9 million in Q3 2023 [52] - Cash balance at the end of Q3 was $565.3 million, up $64.4 million from the prior quarter [52] Business Line Performance - DAYBUE sales were driven by continued penetration of the prevalent population and increased demand among continuing patients, with 923 patients receiving paid shipments in Q3 [21][22] - NUPLAZID achieved its highest-ever quarterly sales of $159.2 million, driven by increased active patients across all market segments [33] - DAYBUE has over 60% of active patients on treatment for 10 months or more, with persistency rates at 50% or higher beyond 12 months [23] - NUPLAZID's growth was supported by real-world evidence studies and label clarification, leading to higher demand and market share [34] Market Performance - DAYBUE has expanded its prescriber base to approximately 800 unique prescribers, with increasing penetration outside of RETT centers of excellence [24][25] - NUPLAZID benefited from a stable Parkinson's disease psychosis market and the launch of direct-to-consumer campaigns, which are expected to drive growth in 2025 [35][37] - DAYBUE received approval in Canada and is targeting a marketing authorization application submission in the EU in Q1 2025 [39][40] Company Strategy and Industry Competition - The company is focused on growing its commercial franchises (DAYBUE and NUPLAZID) and advancing its pipeline, including late-stage assets for Prader-Willi Syndrome and Alzheimer's disease psychosis [9][10] - Acadia is actively pursuing business development opportunities to expand its pipeline and set its growth trajectory for the future [20] - The company is leveraging real-world evidence and caregiver-reported benefits to drive adoption of DAYBUE and NUPLAZID [26][27] Management Commentary on Operating Environment and Future Outlook - Management highlighted the strong foundation of the business and the potential for future growth in both DAYBUE and NUPLAZID [57] - The company expects to see growth in both franchises in 2025, with DAYBUE sales guidance narrowed to $340-$350 million and NUPLAZID sales guidance narrowed to $600-$610 million [54] - The company is confident in its growth outlook based on the current rate of new patient starts and a growing base of enduring patients [32] Other Important Information - The company sold its rare pediatric disease priority review voucher for $150 million, with $50 million to be paid to Neuren as part of a licensing agreement [53] - Acadia is preparing for the European launch of DAYBUE, with plans to build out its team and expertise in Europe [39][94] Q&A Session Summary Question: Business Development and Early-Stage Pipeline - The company is focused on business development to complement its strong neuropsychiatry and rare disease franchises, with a strong financial position to support future deals [62][64] Question: DAYBUE Patient Dynamics and Holiday Season Impact - The company has a better understanding of the reverification process and a more mature patient base heading into 2025, which provides a dependable base for Q1 demand [66][67] Question: NUPLAZID Patient Profile and Label Change Impact - The mix of prescribers and patient age has remained consistent post-campaign launch, with no substantial change in patient demographics [71][72] Question: DAYBUE Sales and Patient Persistency - Over 60% of DAYBUE patients are on treatment for 10 months or more, with persistency rates flattening beyond 10 months, indicating a strong enduring patient base [76] - Discontinuations are primarily due to tolerability issues (diarrhea or vomiting) rather than lack of treatment effect [77] Question: DAYBUE Launch Strategy and Growth Focus - The company is focusing on enhancing efficacy messaging, managing the patient journey, and driving growth outside of centers of excellence to recharge DAYBUE growth [79][80][81] Question: DAYBUE Prescriber Dynamics - The company is focused on driving depth of prescribing among HCPs who have prescribed DAYBUE to one or two patients, with additional patients under their care [86][87] Question: DAYBUE International Expansion - The company is preparing for the Canadian launch of DAYBUE, with limited coverage expected in 2025 through private payers, and is targeting EU and Japan for future expansion [90][94] Question: European Rare Disease Launch Strategy - The company plans to launch DAYBUE in Europe post-registrational approval, with a focus on national HTA negotiations and leveraging its experience in managing rare disease launches [97][98] Question: ACP-204 Master Protocol and Data Release - The company plans to release Phase 2 data for ACP-204 at an appropriate time, with the potential to use the data to modify Phase 3 studies [102][113] Question: CEO's Vision for Acadia - The new CEO is focused on growing the commercial base, advancing the pipeline, and leveraging the company's strong financial position for future growth [114][115] Question: DAYBUE Growth Bottlenecks - The company is focused on educating physicians and caregivers about DAYBUE's real-world efficacy and clinical benefits to drive further adoption [119][120] Question: DAYBUE Patient Restarts - The company is working on strategies to address tolerability challenges and encourage restarts among patients who discontinued treatment, with restarts currently representing less than 10% of the patient base [125][126]

() ACADIA Third Quarter 2024 Earnings Call November 6, 2024 Call Agenda CEO Opening Remarks Catherine Owen Adams | Chief Executive Officer Commercial Update Brendan Teehan | Chief Operating Officer, Head of Commercial R&D Update Elizabeth H.Z. Thompson | Executive Vice President, Head of Research and Development Financial Update Mark Schneyer | Chief Financial Officer Welcome Al Kildani | Senior Vice President, Investor Relations and Corporate Communications Closing Remarks Catherine Owen Adams | Chief Exec ...

Core Insights - Acadia Pharmaceuticals reported quarterly earnings of $0.20 per share, exceeding the Zacks Consensus Estimate of $0.13 per share, and showing a significant improvement from a loss of $0.40 per share a year ago, resulting in an earnings surprise of 53.85% [1] - The company achieved revenues of $250.4 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 0.46% and reflecting a year-over-year increase from $211.7 million [2] - Acadia shares have underperformed the market, losing approximately 52.1% since the beginning of the year, while the S&P 500 has gained 21.2% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.08 on revenues of $255.72 million, and for the current fiscal year, it is $0.51 on revenues of $952.8 million [7] - The estimate revisions trend for Acadia is mixed, leading to a Zacks Rank 3 (Hold) for the stock, 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 ranked in the top 38% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8] - Another company in the same industry, Fortrea Holdings Inc., is expected to report quarterly earnings of $0.27 per share, reflecting a year-over-year change of +12.5%, with revenues anticipated to be $674.08 million, down 13.2% from the previous year [9][10]

Product Portfolio - NUPLAZID and DAYBUE are the company's commercial portfolio products, with NUPLAZID approved in April 2016 and DAYBUE in March 2023[86][99]. - The FDA approved DAYBUE for the treatment of Rett syndrome, making it the first and only drug approved for this condition in the U.S.[86]. - DAYBUE received marketing authorization in Canada for the treatment of Rett syndrome in October 2024, marking it as the first approved drug for this condition in Canada[93]. Research and Development - The company has incurred significant research and development expenses, with a focus on products like pimavanserin, trofinetide, ACP-101, and ACP-204[102]. - The company initiated a Phase 3 study for ACP-101 in November 2023, targeting hyperphagia in Prader-Willi syndrome[94]. - Research and development expenses decreased to $66.6 million for the three months ended September 30, 2024, from $157.0 million for the same period in 2023[114]. - Research and development expenses for the nine months ended September 30, 2024, totaled $202.5 million, down from $284.9 million in 2023[122]. Financial Performance - As of September 30, 2024, the company reported an accumulated deficit of $2.3 billion, indicating substantial operating losses primarily due to research and development expenditures[97]. - Net product sales for the three months ended September 30, 2024, were $250.4 million, an increase from $211.7 million in 2023[111]. - Net product sales of NUPLAZID increased to $159.2 million for the three months ended September 30, 2024, compared to $144.8 million in 2023, reflecting a growth of $14.4 million[112]. - Net product sales of DAYBUE rose to $91.2 million for the three months ended September 30, 2024, up from $66.9 million in 2023, an increase of $24.3 million[112]. - Net product sales for the nine months ended September 30, 2024, were $698.2 million, compared to $495.4 million in 2023[116]. - Net product sales of NUPLAZID for the nine months ended September 30, 2024, were $446.5 million, an increase of $41.2 million from $405.3 million in 2023[117]. - Net product sales of DAYBUE surged to $251.7 million for the nine months ended September 30, 2024, compared to $90.1 million in 2023, an increase of $161.6 million[117]. Expenses - Selling, general and administrative expenses increased to $133.3 million for the three months ended September 30, 2024, from $97.9 million in 2023[115]. - Selling, general and administrative expenses increased to $358.3 million for the nine months ended September 30, 2024, from $295.1 million for the same period in 2023, representing a 21.4% increase[123]. - The increase in selling, general and administrative expenses was primarily driven by costs related to the consumer activation program for the NUPLAZID franchise and increased marketing costs in the U.S.[123]. - Cost of product sales for the nine months ended September 30, 2024, was $60.0 million, representing approximately 9% of net product sales, compared to $23.7 million or 5% in 2023[119]. Cash Flow and Financing - Net cash provided by operating activities increased to $117.3 million for the nine months ended September 30, 2024, compared to a net cash used of $68.7 million for the same period in 2023[132]. - Cash, cash equivalents, and investment securities totaled $565.3 million at September 30, 2024, up from $438.9 million at December 31, 2023, marking a $126.4 million increase[132]. - Net cash used in investing activities totaled $152.7 million for the nine months ended September 30, 2024, compared to $32.3 million of net cash provided in the same period in 2023[133]. - Net cash provided by financing activities decreased to $4.9 million for the nine months ended September 30, 2024, down from $19.7 million for the same period in 2023[134]. - The company expects cash, cash equivalents, and securities to be sufficient to fund planned operations through and beyond the next 12 months[124]. - The company may require additional financing in the future to fund operations, depending on various factors including the costs of acquiring additional product candidates[124]. - The company is required to make milestone payments of $50.0 million within 60 days following Neuren's invoice delivery after December 31, 2024, due to exceeding $250.0 million in net revenue from trofinetide in North America[130]. Licensing and Market Expansion - The company expanded its licensing agreement with Neuren in July 2023, acquiring global rights for trofinetide and NNZ-2591, with potential milestone payments totaling up to $1.257 billion[92]. - The company is exploring additional markets for trofinetide, with plans for a filing in Europe anticipated in Q1 2025[93]. - The company has fulfilled one of the five post-marketing requirements for DAYBUE and is awaiting FDA's acknowledgment for another completed requirement[102]. Investment Portfolio - The investment portfolio has not been adversely impacted by past disruptions in credit markets, but future disruptions could affect it[127].