MAY 7, 2025 First Quarter 2025 Earnings Call Call Agenda | Welcome | Al Kildani Senior Vice President, Investor Relations and Corporate Communications | | --- | --- | | CEO Opening Remarks | Catherine Owen Adams Chief Executive Officer | | Commercial Update | Tom Garner Executive Vice President, Chief Commercial Officer | | R&D Update | Elizabeth H.Z. Thompson Executive Vice President, Head of Research and Development | | Financial Update | Mark Schneyer Executive Vice President, Chief Financial Officer | | ...

Financial Performance - Total revenues for the first quarter of 2025 were $244.3 million, representing a 19% increase year-over-year[1] - NUPLAZID® net product sales reached $159.7 million, up 23% compared to $129.9 million in the first quarter of 2024[6] - DAYBUE® net product sales were $84.6 million, an 11% increase from $75.9 million in the same quarter last year[7] - Net income for the first quarter of 2025 was $19.0 million, or $0.11 per share, compared to $16.6 million, or $0.10 per share, for the same period in 2024[10] Revenue Guidance - The company expects full year 2025 revenue guidance of $1.03 to $1.095 billion, with NUPLAZID net sales projected between $650 to $690 million and DAYBUE net sales between $380 to $405 million[13] Expenses - Research and development expenses increased to $78.3 million from $59.7 million in the first quarter of 2024, primarily due to costs from clinical stage programs[8] - Selling, general and administrative expenses rose to $126.4 million from $108.0 million in the same period last year, driven by costs related to the consumer activation program for NUPLAZID[9] Patient Metrics - The company achieved a record high of 954 unique patients receiving DAYBUE shipments in the first quarter[5] Future Plans - Acadia plans to submit a New Drug Application for ACP-101 in the first quarter of 2026, pending positive results from the COMPASS PWS Phase 3 study expected in early Q4 2025[5] Cash Position - Cash, cash equivalents, and investment securities totaled $681.6 million as of March 31, 2025, down from $756.0 million at the end of 2024[11]

Core Insights - The Medical sector is experiencing a robust first-quarter earnings season, with several drugmakers reporting results, and large caps like J&J, Merck, and Amgen exceeding earnings and sales estimates [1][2] - Overall, first-quarter earnings for the Medical sector are projected to rise by 40%, with revenues expected to increase by 8.3% [3] Earnings Performance - As of April 30, 45% of Medical sector companies, representing approximately 57.9% of the sector's market capitalization, have reported earnings, with 66.7% beating both earnings and revenue estimates [2] - Year-over-year earnings growth for the sector is reported at 60.5%, while revenues have increased by 7.8% [2] Company Highlights - **Novo Nordisk**: Expected to report earnings of 92 cents per share and revenues of $11.33 billion, with strong sales anticipated from diabetes and obesity care products [6][7] - **Pacira BioSciences**: Projected earnings of 57 cents per share and revenues of $174.96 million, driven by sales of its pain-management product Exparel [8][9] - **Ultragenyx Pharmaceuticals**: Expected to report a loss of $1.54 per share and revenues of $141.99 million, with growth driven by its lead drug Crysvita [10][11] - **Acadia Pharmaceuticals**: Anticipated earnings of 6 cents per share and revenues of $241.74 million, primarily from sales of Nuplazid for Parkinson's disease psychosis [12][13] - **Denali Therapeutics**: Expected loss of 71 cents per share and revenues of $8.3 million, with updates on pipeline programs anticipated during the earnings report [17][18] Earnings Surprise Potential - The Earnings ESP methodology indicates that stocks with a positive Earnings ESP and a Zacks Rank of 1, 2, or 3 have a high chance of delivering earnings surprises, with a success rate of up to 70% [4][5]

Company Overview - Acadia Pharmaceuticals (ACAD) shares increased by 6.1% to $14.96, following a significant trading volume, contrasting with an 18% decline over the past four weeks [1] - The company is expected to report quarterly earnings of $0.05 per share, reflecting a 50% decrease year-over-year, while revenues are projected to be $241.58 million, marking a 17.4% increase from the previous year [2] Earnings Estimates and Trends - The consensus EPS estimate for Acadia has remained stable over the last 30 days, indicating that stock price movements may not sustain without changes in earnings estimate revisions [3] - The stock currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook [3] Industry Comparison - Acadia operates within the Zacks Medical - Biomedical and Genetics industry, where Kiniksa Pharmaceuticals (KNSA) also resides, closing 2.2% higher at $19.90, despite a -9.6% return over the past month [3] - Kiniksa's consensus EPS estimate is $0.06, representing a 124% increase compared to the previous year's EPS, and it holds a Zacks Rank of 2 (Buy) [4]

Company Overview - Acadia Pharmaceuticals has experienced an 11.1% decline in share price over the past month, underperforming the S&P 500 [1] - The most recent earnings report indicates a significant downward trend in estimates, with a consensus estimate shift of -62.99% [2] Performance Metrics - Acadia holds a Growth Score of B, but has a low Momentum Score of F, while achieving a Value Score of B, placing it in the top 40% for this investment strategy [3] - The aggregate VGM Score for Acadia is B, which is relevant for investors not focused on a single strategy [3] Outlook - The overall trend for Acadia's estimates is downward, with a Zacks Rank of 3 (Hold), suggesting an expectation of in-line returns in the coming months [4] Industry Comparison - Acadia is part of the Zacks Medical - Biomedical and Genetics industry, where Halozyme Therapeutics has seen an 11.8% increase in share price over the past month [5] - Halozyme Therapeutics reported revenues of $298.01 million for the last quarter, reflecting a year-over-year growth of +29.6%, with an EPS of $1.26 compared to $0.82 a year ago [6] - For the current quarter, Halozyme is expected to report earnings of $0.98 per share, indicating a year-over-year change of +24.1% [6] - Halozyme also holds a Zacks Rank of 3 (Hold) and has a VGM Score of B [7]

Company Performance - Acadia Pharmaceuticals reported fourth-quarter earnings of $0.17 per share, missing the Zacks Consensus Estimate of $0.19 per share, and down from $0.28 per share a year ago [1] - The company posted GAAP earnings per share of 86 cents for the quarter [1] - The earnings surprise for this quarter was -10.53%, while the previous quarter saw a positive surprise of 53.85% with actual earnings of $0.20 per share against an expected $0.13 [2] Revenue Insights - Acadia's revenues for the quarter ended December 2024 were $259.6 million, exceeding the Zacks Consensus Estimate by 1.79%, and up from $231.04 million year-over-year [3] - The company has surpassed consensus revenue estimates three times over the last four quarters [3] Market Performance - Acadia shares have increased by approximately 3.6% since the beginning of the year, outperforming the S&P 500's gain of 1.3% [4] - The stock's immediate price movement will depend on management's commentary during the earnings call [4] Future Outlook - The current consensus EPS estimate for the upcoming quarter is $0.14 on revenues of $235.58 million, and for the current fiscal year, it is $0.76 on revenues of $1.04 billion [8] - The estimate revisions trend for Acadia is currently unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [7] Industry Context - Acadia operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 24% of over 250 Zacks industries [9] - The performance of Acadia's stock may be influenced by the overall outlook for the industry, as the top 50% of Zacks-ranked industries tend to outperform the bottom 50% by a factor of more than 2 to 1 [9]

Core Viewpoint - Acadia Pharmaceuticals reported mixed financial results for Q4 2024, with earnings per share missing estimates but total revenues exceeding expectations, driven by the performance of its products Nuplazid and Daybue [1][2][9]. Financial Performance - Acadia reported Q4 2024 earnings of 17 cents per share, below the Zacks Consensus Estimate of 19 cents, while GAAP earnings per share were 86 cents [1]. - Total revenues for Q4 2024 reached $259.6 million, surpassing the Zacks Consensus Estimate of $255 million, marking a 12% year-over-year increase [2][4]. - For the full year 2024, Acadia's total revenues were $957.8 million, a 32% increase year over year, exceeding the Zacks Consensus Estimate of $953.2 million [9]. Product Performance - Nuplazid generated revenues of $162.9 million in Q4 2024, a 13% increase year over year, outperforming the Zacks Consensus Estimate of $160.4 million [5]. - Daybue recorded net product sales of $96.7 million in Q4 2024, an 11% year-over-year increase, also beating the Zacks Consensus Estimate of $94.4 million [6]. Expenses - Research and development (R&D) expenses for Q4 2024 were $100.7 million, up 51% year over year, primarily due to increased costs from clinical-stage programs [7]. - Selling, general and administrative (SG&A) expenses were $130.1 million, a 17% increase year over year, attributed to higher marketing costs for Nuplazid and Daybue [8]. Financial Outlook - For 2025, Acadia expects total revenues from U.S. sales to be between $1.030 billion and $1.095 billion, with Nuplazid sales projected at $650 million to $690 million and Daybue sales expected to be between $380 million and $405 million [10]. - R&D expenses for 2025 are projected to be between $310 million and $330 million, while SG&A expenses are expected to range from $535 million to $565 million [12]. Regulatory and Development Updates - Acadia has a regulatory filing for Daybue in the EU under review, with approval expected in Q1 2026 [13]. - The company plans to enroll the last patient in the phase III COMPASS PWS study for ACP-101 in Q4 2025, with top-line data anticipated in H1 2026 [14]. - Acadia is also preparing to initiate a mid-stage study for ACP-204 targeting Alzheimer's disease psychosis in Q1 2026 [15]. - The company signed a license agreement with Saniona to develop ACP711 for essential tremor, with plans for a mid-stage study in 2026 [16][17].

Group 1 - The biotech forum has seen significant discussions around profitable buy-write or covered call strategies on selected biotech stocks in recent months [1] - ACADIA Pharmaceuticals reported its fourth quarter results and provided initial guidance for FY2025, indicating a positive outlook for the upcoming year [2] - The company also shared an encouraging update regarding its pipeline, suggesting potential growth opportunities [2] Group 2 - The investing group, The Biotech Forum, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live discussions on trade ideas and weekly market commentary [2]

Revenue and Market Performance - Net product sales from NUPLAZID and DAYBUE totaled $957.8 million for 2024, up from $726.4 million in 2023, representing a 31.7% increase[20] - The company estimates that approximately 130,000 Parkinson's disease patients are treated with an atypical antipsychotic annually in the U.S., with NUPLAZID capturing about 20% of this market[31] - DAYBUE is the first and only drug approved for the treatment of Rett syndrome, with an estimated prevalent population of 6,000 to 9,000 patients in the U.S.[40] - The company anticipates initial revenues from managed access programs for DAYBUE in certain European Union countries in 2025[28] - The company completed the sale of a Rare Pediatric Disease Priority Review Voucher for $150 million in December 2024[41] - Substantially all of the company's revenues since May 2016 were from U.S. net product sales of NUPLAZID and DAYBUE[197] Product Development and Clinical Trials - The company plans to initiate a Phase 2 study of ACP-204 in Lewy Body Dementia with Psychosis in Q3 2025, following the initiation of a Phase 2 study for Alzheimer's disease psychosis in November 2023[23] - ACP-101 is being evaluated in a Phase 3 study for hyperphagia in Prader-Willi syndrome (PWS) with an expected enrollment completion in Q4 2025 and top-line results in H1 2026[46][47] - The Phase 3 COMPASS PWS study will involve approximately 170 participants aged 5 to 30 years, assessing the efficacy of carbetocin nasal spray 3.2 mg three times daily[46] - ACP-204 is in Phase 2 for treating hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP), with an enrollment target of approximately 318 patients[52] - The Phase 2 RADIANT study for ACP-204 is expected to complete enrollment in Q1 2026, with top-line results anticipated around mid-2026[53] - ACP-711, licensed from Saniona, is intended for essential tremor treatment, with a Phase 2 study planned for 2026 after completing Phase 1[56][59] Regulatory and Compliance - The marketing authorization application (MAA) for DAYBUE was submitted to the European Medicines Agency (EMA) in January 2025, with expected approval in Q1 2026[43] - The FDA granted marketing authorization for DAYBUE in Canada in October 2024, with first commercial sales expected by Q3 2025[42] - The company is subject to extensive regulation by governmental authorities, impacting the development, testing, and marketing of its products[82] - The FDA's review process for New Drug Applications (NDAs) can take up to 12 months for standard reviews, with potential delays due to additional information requests[85] - The company must comply with the Clinical Trials Regulation (EU) No 536/2014, which streamlines clinical trial authorizations and reporting procedures across EU Member States[110] - The company is subject to various healthcare regulations, including the federal Anti-Kickback Statute and False Claims Act, which impose significant penalties for violations[98] Intellectual Property - The company holds approximately 54 issued U.S. patents and has licensed an additional 23 patents, emphasizing the importance of intellectual property in its business strategy[69] - The company holds exclusive licenses to 8 U.S. patents related to trofinetide, with a key patent for treating Rett syndrome expiring in 2032, potentially extendable to January 2036[74] - The company has obtained six additional U.S. patents for pimavanserin, with two patents expiring in 2037 and four in 2038[73] - The company continues to file and prosecute patent applications for ACP-101, with patents expiring in 2035 and 2039[76] - The company holds two U.S. patents for ACP-204, with the composition patent expiring in 2038[78] - The company continues to prosecute patent applications worldwide for its product candidates, ensuring ongoing protection and potential market exclusivity[75] Market Access and Reimbursement - Coverage and reimbursement from third-party payors are critical for product acceptance, and inadequate coverage could diminish revenue generation[166] - The market for products is heavily influenced by access to third-party payors' drug formularies, which can lead to pricing pressures[167] - Legislative measures in the EU and UK may impose cost-containment strategies affecting pricing and reimbursement levels for new products[168] - The company may be required to compile additional data comparing the cost-effectiveness of its products to other available therapies for reimbursement in some European countries[127] Financial Condition and Future Outlook - As of December 31, 2024, the company had an accumulated deficit of approximately $2.2 billion[196] - The company expects its cash, cash equivalents, and investment securities will be sufficient to fund planned operations through and beyond the next 12 months[198] - The company has experienced significant net losses since inception and anticipates increasing expenses in the coming years[196] - The company may require additional financing in the future to fund operations, which could significantly dilute existing stockholders[199] - The company’s future capital requirements could increase significantly due to various factors, including the costs of acquiring additional product candidates[199] Operational Risks - The company faces risks related to delays, suspensions, and terminations in clinical trials, which could harm commercial prospects[190] - The company’s success depends on attracting and retaining qualified personnel, particularly in the fields of CNS disorders and rare diseases[191] - Global economic conditions, including inflation and supply chain disruptions, could adversely affect the company's financial condition and operational results[209] - A prolonged global economic downturn may increase operating costs and limit access to credit, impacting liquidity and capital raising efforts[210] Manufacturing and Supply Chain - The company has contracted with manufacturers to produce supplies of trofinetide to support the development program and for commercial sale, with the initial term of the manufacturing agreement ending in November 2027[137] - The company has licensed worldwide intellectual property rights related to pimavanserin to Acadia Pharmaceuticals GmbH, which manages the worldwide supply chain of the active pharmaceutical ingredient (API)[132] - The company outsources manufacturing activities for its products, allowing it to direct financial resources to commercial activities and ongoing development[131] - The company has contracted with Patheon Pharmaceuticals Inc. to manufacture NUPLAZID for commercial use in the United States, with the initial term of the manufacturing agreement ending in the first quarter of 2023[135] Commercial Strategy - The company aims to maximize growth of NUPLAZID by enhancing consumer activation and increasing field force efficiency, targeting a significant portion of the Parkinson's disease market[28] - The company has a commercial team focused on marketing and sales, including specialists for both NUPLAZID and DAYBUE[143][145] - The commercial success of NUPLAZID and DAYBUE is dependent on acceptance by patients, caregivers, and physicians, with no approved competitors currently available[159][163] - The label for NUPLAZID includes a "boxed" warning, which may affect prescribing patterns and perceptions of safety[162] Collaboration and Partnerships - The company has entered into a collaboration with Stoke Therapeutics for RNA-based medicines targeting severe genetic neurodevelopmental diseases, currently in various discovery stages[63] - The company relies on collaborations with third parties for product development and commercialization, which may be affected by resource allocation and strategic focus changes[215] - Conflicts in collaborations may arise, potentially delaying product development and increasing costs due to disputes over strategy and payment responsibilities[217]

Core Insights - Acadia Pharmaceuticals reported fourth-quarter 2024 earnings of 17 cents per share, missing the Zacks Consensus Estimate of 19 cents, and adjusted for a one-time sale of a Rare Pediatric Disease Priority Review Voucher [1] - Total revenues for the quarter were $259.6 million, exceeding the Zacks Consensus Estimate of $255 million, with significant contributions from its two marketed products, Nuplazid and Daybue [2][4] Financial Performance - Revenues from Nuplazid increased 13% year over year to $162.9 million, surpassing the Zacks Consensus Estimate of $160.4 million [5] - Daybue recorded net product sales of $96.7 million, up 11% year over year, also beating the Zacks Consensus Estimate of $94.4 million [6] - For the full year 2024, Acadia's total revenues reached $957.8 million, a 32% increase year over year, exceeding the Zacks Consensus Estimate of $953.2 million [9] Expense Overview - Research and development (R&D) expenses rose 51% year over year to $100.7 million, primarily due to increased costs from clinical-stage programs [7] - Selling, general and administrative (SG&A) expenses increased 17% year over year to $130.1 million, attributed to higher marketing costs for Nuplazid and Daybue [8] Future Outlook - Acadia expects total revenues from U.S. sales of its products in 2025 to range between $1.030 billion and $1.095 billion, with Nuplazid sales projected between $650 million and $690 million, and Daybue sales expected between $380 million and $405 million [10][12] - R&D expenses for 2025 are projected to be between $310 million and $330 million, while SG&A expenses are expected to be between $535 million and $565 million [12] Product Development Updates - A regulatory filing for Daybue to treat Rett syndrome in the EU is under review, with approval expected in Q1 2026 [13] - Acadia plans to enroll the last patient in the phase III COMPASS PWS study for ACP-101 in Q4 2025, with top-line data expected in H1 2026 [14] - The company anticipates initiating a mid-stage study for ACP-204 for Lewy Body dementia psychosis in Q3 2025 [15] - Acadia signed a worldwide license agreement with Saniona to develop ACP711 for essential tremor, with a mid-stage study planned for 2026 [16][17]