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ACADIA Pharmaceuticals(ACAD) - 2024 Q3 - Quarterly Report
2024-11-06 22:41
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].
ACADIA Pharmaceuticals(ACAD) - 2024 Q3 - Quarterly Results
2024-11-06 21:14
Exhibit 99.1 Acadia Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operating Overview - 3Q24 total revenues of $250.4 million, up 18% year-over-year - 3Q24 NUPLAZID® (pimavanserin) net product sales of $159.2 million, up 10% year-over-year - 3Q24 DAYBUE™ (trofinetide) net product sales of $91.2 million, up 36% year-over-year SAN DIEGO, CA, November 6, 2024 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the third quarter ended September 30, 2024. "The ...
Why Acadia (ACAD) Could Beat Earnings Estimates Again
ZACKS· 2024-10-14 17:11
If you are looking for a stock that has a solid history of beating earnings estimates and is in a good position to maintain the trend in its next quarterly report, you should consider Acadia Pharmaceuticals (ACAD) . This company, which is in the Zacks Medical - Biomedical and Genetics industry, shows potential for another earnings beat. This drugmaker has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. The average surprise for the last two quarters was ...
ACAD or TECH: Which Is the Better Value Stock Right Now?
ZACKS· 2024-10-09 16:48
Investors with an interest in Medical - Biomedical and Genetics stocks have likely encountered both Acadia Pharmaceuticals (ACAD) and Techne (TECH) . But which of these two stocks is more attractive to value investors? We'll need to take a closer look to find out. Everyone has their own methods for finding great value opportunities, but our model includes pairing an impressive grade in the Value category of our Style Scores system with a strong Zacks Rank. The proven Zacks Rank emphasizes companies with pos ...
Acadia (ACAD) Up 10% Since Last Earnings Report: Can It Continue?
ZACKS· 2024-09-05 16:37
A month has gone by since the last earnings report for Acadia Pharmaceuticals (ACAD) . Shares have added about 10% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Acadia due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts. Acadia Q2 Earnings Beat, Product Sales Drive ...
Acadia (ACAD) Q2 Earnings Beat, Product Sales Drive Revenues
ZACKS· 2024-08-07 13:21
Acadia Pharmaceuticals Inc. (ACAD) reported second-quarter 2024 earnings of 20 cents per share, beating the Zacks Consensus Estimate of 16 cents. In the year-ago quarter, the company had recorded earnings of 1 cent per share.The bottom line improved year over year owing to higher product sales.Acadia recorded total revenues of $242 million, which beat the Zacks Consensus Estimate of $235 million. ACAD’s net product revenues comprise revenues generated from the sale of its two marketed products, Nuplazid (pi ...
ACADIA Pharmaceuticals(ACAD) - 2024 Q2 - Earnings Call Transcript
2024-08-07 02:15
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) Q2 2024 Earnings Conference Call August 6, 2024 4:30 PM ET Company Participants Al Kildani - Senior Vice President, Investor Relations and Corporate Communications Steve Davis - President and Chief Executive Officer Brendan Teehan - Chief Operating Officer, Head of Commercial Kimberly Manhard - Senior Vice President, Global Strategic Planning and Execution Mark Schneyer - Chief Financial Officer Parag Meswani - Senior Vice President, Trofinetide Elizabeth Thompson - ...
ACADIA Pharmaceuticals(ACAD) - 2024 Q2 - Quarterly Report
2024-08-06 23:48
Commercial Products - NUPLAZID and DAYBUE are the company's commercial portfolio products, with NUPLAZID approved in April 2016 and DAYBUE in March 2023[87][98]. - The FDA approved DAYBUE for Rett syndrome, with the product launched in the U.S. in April 2023, following positive results from the Phase 3 LAVENDER™ study[89][98]. - The company holds worldwide commercialization rights to NUPLAZID and has a strategy to expand its pipeline through strategic business development[88][86]. Financial Performance - Net product sales for the three months ended June 30, 2024, were $242.0 million, up from $165.2 million in the same period of 2023, representing a 46.5% increase[111]. - Net product sales of NUPLAZID increased to $157.4 million for the three months ended June 30, 2024, compared to $142.0 million in 2023, a growth of $15.4 million[111]. - Net product sales of DAYBUE surged to $84.6 million for the three months ended June 30, 2024, from $23.2 million in 2023, reflecting an increase of $61.4 million[111]. Research and Development - The company has incurred substantial operating losses and expects to continue incurring losses due to significant research and development costs[96]. - Research and development expenses for the first half of 2024 are expected to increase due to advancements in early-stage development pipeline programs[101]. - The company anticipates that research and development expenses will remain substantial as it continues to develop ACP-101, ACP-204, and other early-stage programs[106]. - The company is developing ACP-204 for Alzheimer's disease psychosis, with a Phase 2 study initiated in November 2023[94]. Operating Expenses - Selling, general and administrative expenses increased to $117.1 million for the three months ended June 30, 2024, from $96.0 million in 2023, a rise of 22.0%[116]. - Selling, general and administrative expenses increased to $225.1 million for the six months ended June 30, 2024, up from $197.2 million for the same period in 2023, driven by costs related to a new consumer activation program and increased marketing expenses[123]. - The increase in selling, general and administrative expenses was primarily driven by upfront costs related to the NUPLAZID franchise and investments for commercialization of trofinetide outside the U.S.[123]. Cash Flow and Financing - Cash, cash equivalents, and investment securities totaled $500.9 million at June 30, 2024, an increase of $62.0 million from $438.9 million at December 31, 2023, primarily due to cash provided by operating activities[131]. - Net cash provided by operating activities increased to $54.1 million for the six months ended June 30, 2024, compared to a net cash used of $9.7 million for the same period in 2023[131]. - Future capital requirements may increase significantly due to costs associated with acquiring additional product candidates and the scope of research and development programs[125]. - The company may require additional financing in the future, which could be affected by market conditions and the ability to generate cash from operations[127]. - The company expects its cash, cash equivalents, and investment securities to be sufficient to fund planned operations through and beyond the next 12 months[124]. Licensing and Agreements - The expanded licensing agreement with Neuren in July 2023 included an upfront payment of $100 million and potential milestone payments of up to $1.257 billion[91]. - The company plans to file for pediatric investigation plan approval in Europe in Q1 2025 and has initiated discussions with regulatory agencies in Japan and Canada[92]. - The company plans to make milestone payments of $50.0 million in the next 12 months if aggregate net revenue of trofinetide in North America exceeds $250.0 million[130]. Cost of Sales - The cost of sales for DAYBUE was affected by the use of initial pre-launch inventory, with expectations that costs will stabilize as full-cost inventories are sold[100]. - Cost of product sales for the six months ended June 30, 2024, was $41.2 million, compared to $9.1 million in 2023, representing an increase of 352.7%[119]. - License fees and royalties for DAYBUE increased to $23.7 million for the six months ended June 30, 2024, from $3.7 million in the same period of 2023[119].
ACADIA Pharmaceuticals(ACAD) - 2024 Q2 - Earnings Call Presentation
2024-08-06 23:24
○ ACADIA Second Quarter 2024 Earnings Call August 6, 2024 Call Agenda Welcome Al Kildani | Senior Vice President, Investor Relations and Corporate Communications CEO Opening Remarks Steve Davis | President and Chief Executive Officer Commercial Update Brendan Teehan | Chief Operating Officer, Head of Commercial R&D Update Elizabeth Thompson | Executive Vice President, Head of Research and Development Financial Update Mark Schneyer | Chief Financial Officer Closing Remarks Steve Davis | President and Chief E ...
Acadia Pharmaceuticals (ACAD) Beats Q2 Earnings and Revenue Estimates
ZACKS· 2024-08-06 22:47
分组1 - Acadia Pharmaceuticals reported quarterly earnings of $0.20 per share, exceeding the Zacks Consensus Estimate of $0.16 per share, and showing a significant increase from $0.01 per share a year ago, representing an earnings surprise of 25% [1] - The company achieved revenues of $241.96 million for the quarter ended June 2024, surpassing the Zacks Consensus Estimate by 2.85%, and up from $165.24 million year-over-year [1] - Over the last four quarters, Acadia has surpassed consensus EPS estimates three times and has also topped consensus revenue estimates three times [1] 分组2 - The current consensus EPS estimate for the upcoming quarter is $0.13 on revenues of $251.11 million, while for the current fiscal year, the estimate is $0.58 on revenues of $952.88 million [4] - The Medical - Biomedical and Genetics industry, to which Acadia belongs, is currently ranked in the top 37% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [5] - G1 Therapeutics, another company in the same industry, is expected to report a quarterly loss of $0.17 per share, reflecting a year-over-year change of -221.4%, with revenues anticipated to be $15.88 million, down 62.6% from the previous year [5][6]