ACADIA PHARMACEUTICALS INC

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes thereto included in this Quarterly Report on Form 10-Q (this Quarterly Report), the audited financial statements and notes thereto as of and for the year ended December 31, 2025 included with our Annual Report on Form 10-K, filed with the SEC on February 26, 2026 (our Annual Report), and our unaudited condensed consolidated financial statements and related notes thereto as of and for the quarter ended March 31, 2026 included with our Quarterly Report on Form 10-Q, filed with the SEC on May 7, 2026. Past operating results are not necessarily indicative of results that may occur in future periods.

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes thereto included in this Quarterly Report on Form 10-Q (this Quarterly Report), the audited financial statements and notes thereto as of and for the year ended December 31, 2025 included with our Annual Report on Form 10-K, filed with the SEC on February 26, 2026 (our Annual Report), our unaudited condensed consolidated financial statements and related notes thereto as of and for the quarter ended March 31, 2026 included with our Quarterly Report on Form 10-Q, filed with the SEC on May 7, 2026, and our unaudited condensed consolidated financial statements and related notes thereto as of and for the quarter ended June 30, 2026 included with our Quarterly Report on Form 10-Q, filed with the SEC on August 5, 2026. Past operating results are not necessarily indicative of results that may occur in future periods.

Previous wording

We have two core franchises in neurological and rare diseases. Our neurological franchise is anchored by the commercial product NUPLAZID (pimavanserin), which is the first and only drug approved by the FDA for the treatment of hallucinations and delusions associated with PDP. Our rare disease franchise is anchored by the DAYBUE products, which are the first and only drug approved for the treatment of Rett syndrome. Net product sales from these two commercial products totaled $576.0 million for the six months ended June 30, 2026, compared with $508.9 million for the six months ended June 30, 2025.

Current wording

We have two core franchises in neurological and rare diseases. Our neurological franchise is anchored by the commercial product NUPLAZID (pimavanserin), which is the first and only drug approved by the FDA for the treatment of hallucinations and delusions associated with PDP. Our rare disease franchise is anchored by the DAYBUE products, which are the first and only drug approved for the treatment of Rett syndrome or neurobehavioral symptoms of Rett syndrome. Net product sales from these two commercial products totaled $918.3 million for the nine months ended September 30, 2026, compared with $787.5 million for the nine months ended September 30, 2025.

Previous wording

In June 2026, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion following a re-examination procedure and recommended the granting of a marketing authorization for trofinetide, known as DAYBU® in the European Union (EU) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If the marketing authorization is granted by the European Commission, DAYBU® would be the first therapy approved for this indication in the EU.

Current wording

In August 2026, the EC granted marketing authorization for DAYBU® (trofinetide) for the treatment of the neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. DAYBU® is the first therapy approved for this indication in the EU. We made our first commercial sale of DAYBU in the EU in October 2026.

Previous wording

Our most advanced current product candidate is remlifanserin for the treatment of Alzheimer’s disease psychosis (ADP) and Lewy Body Dementia Psychosis (LBDP). In November 2023, we initiated our RADIANT Phase 2 study evaluating the efficacy and safety of remlifanserin for the treatment of hallucinations and delusions associated with ADP. We have completed enrollment in the Phase 2 portion of the RADIANT program, initiated screening and enrollment in the Phase 3 portion and expect topline results for the Phase 2 portion between September and October 2026. We initiated an additional Phase 2 study of remlifanserin in LBDP in September 2025. In the fourth quarter of 2025, we initiated a Phase 2 study of ACP-211 for the treatment of major depressive disorder. In July 2026, the FDA granted Fast Track designation for remlifanserin for the treatment of hallucinations and delusions associated with ADP.

Current wording

Our most advanced current product candidate is remlifanserin for the treatment of Alzheimer’s disease psychosis (ADP) and Lewy Body Dementia Psychosis (LBDP). In November 2023, we initiated our RADIANT Phase 2 study evaluating the efficacy and safety of remlifanserin for the treatment of hallucinations and delusions associated with ADP. In July 2026, the FDA granted Fast Track designation for remlifanserin for the treatment of hallucinations and delusions associated with ADP. In September 2026, we announced the topline results from our Phase 2 RADIANT study. The study narrowly missed the primary endpoint of the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (p=0.0603) with significance (nominal) on the key secondary endpoint of Clinical Global Impression – Severity (p=0.0077). However, the study demonstrated meaningful and consistent efficacy trends across endpoints for the once daily 60 mg dose and a favorable safety and tolerability profile across both once daily 30 mg dose and once daily 60 mg dose. These findings achieved the study’s objective of informing dose selection and study design optimization for Phase 3 which we believe supports continuing with Phase 3 development for the once daily 60 mg dose. Therefore, we plan to continue enrolling our two ongoing Phase 3 studies evaluating remlifanserin for the once daily 60 mg dose in ADP while implementing amendments to the Phase 3 program, including removing the once daily 30 mg dosage arm. We initiated an additional Phase 2 study of remlifanserin in LBDP in September 2025 and expect a data readout in the fourth quarter 2027. We received FDA Fast Track designation for remlifanserin in LBDP in August 2026. In the fourth quarter of 2025, we initiated a Phase 2 study of ACP-211 for the treatment of major depressive disorder and expect a data readout in the second half 2027.

Previous wording

We have incurred substantial operating losses since our inception due in large part to expenditures for our research and development activities. As of June 30, 2026, we had an accumulated deficit of approximately $1.8 billion. Contingent on the level of business development activities we may complete as well as pipeline programs we may advance, we may incur operating losses as we incur significant research and development costs and costs for continued commercialization of our products.

Current wording

We have incurred substantial operating losses since our inception due in large part to expenditures for our research and development activities. As of September 30, 2026, we had an accumulated deficit of approximately $1.7 billion. Contingent on the level of business development activities we may complete as well as pipeline programs we may advance, we may incur operating losses as we incur significant research and development costs and costs for continued commercialization of our products.

Previous wording

Net product sales consist of sales of our products. The FDA approved NUPLAZID in April 2016 for the treatment of hallucinations and delusions associated with PDP and we launched the product in the United States in May 2016. The FDA approved DAYBUE in March 2023 for the treatment of Rett syndrome and we launched the product in the United States in April 2023. Health Canada granted marketing authorization of DAYBUE for the treatment of Rett syndrome in adult and pediatric patients 2 years of age and older in October 2024. The Ministry of Health in Israel approved DAYBUE for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older and weighing at least 9 kg in December 2025. The FDA approved DAYBUE STIX in December 2025 for the treatment of Rett syndrome and we made the product available on a limited basis in the first quarter of 2026 followed by a broader launch in the second quarter of 2026. In addition, we currently have contracts with multiple distributors outside the United States that distribute DAYBUE for limited named patient/compassionate use.

Current wording

Net product sales consist of sales of our products. The FDA approved NUPLAZID in April 2016 for the treatment of hallucinations and delusions associated with PDP and we launched the product in the United States in May 2016. The FDA approved DAYBUE in March 2023 for the treatment of Rett syndrome and we launched the product in the United States in April 2023. Health Canada granted marketing authorization of DAYBUE for the treatment of Rett syndrome in adult and pediatric patients 2 years of age and older in October 2024. The Ministry of Health in Israel approved DAYBUE for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older and weighing at least 9 kg in December 2025. The FDA approved DAYBUE STIX in December 2025 for the treatment of Rett syndrome and we made the product available on a limited basis in the first quarter of 2026 followed by a broader launch in the second quarter of 2026. In addition, we currently have contracts with multiple distributors outside the United States that distribute DAYBUE for limited named patient/compassionate use. The EC granted marketing authorization for DAYBU for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five and older in August 2026. Our first commercial sales of DAYBU took place in October 2026.

Previous wording

Our research and development expenses have consisted primarily of fees paid to external service providers, salaries and related personnel expenses, facilities and equipment expenses, and other costs incurred related to pre-commercial product candidates. We charge all research and development expenses to operations as incurred. Our research and development activities have focused on pimavanserin, trofinetide, remlifanserin and other earlier-stage product candidates. In connection with the FDA approval of DAYBUE, we are required to conduct post-marketing work, including a clinical study of renal impairment in healthy volunteers, nonclinical carcinogenicity studies, and nonclinical in vitro and clinical in vivo drug interaction studies. The FDA has released us from one of the five post-marketing requirements (PMRs). In addition, we have fulfilled three of the five PMRs. We will be responsible for all costs incurred for these PMRs. In addition, we expect to incur increased research and development expenses as a result of advancement of our early-stage product candidates.

Current wording

Our research and development expenses have consisted primarily of fees paid to external service providers, salaries and related personnel expenses, facilities and equipment expenses, and other costs incurred related to pre-commercial product candidates. We charge all research and development expenses to operations as incurred. Our research and development activities have focused on pimavanserin, trofinetide, remlifanserin and earlier-stage product candidates. In connection with the FDA approval of DAYBUE, we are required to conduct post-marketing work, including a clinical study of renal impairment in healthy volunteers, nonclinical carcinogenicity studies, and nonclinical in vitro and clinical in vivo drug interaction studies. The FDA has released us from one of the five post-marketing requirements (PMRs). In addition, we have fulfilled three of the five PMRs. We also expect to incur increased research and development expenses as a result of advancement of our early-stage product candidates.

Previous wording

We use external service providers to manufacture our product candidates and for the majority of the services performed in connection with the preclinical and clinical development of our product candidates. Historically, we have used our internal research and development resources, including our employees and discovery infrastructure, across several projects and many of our costs have not been attributable to a specific project. Accordingly, we have not reported our internal research and development costs on a project-by-project basis. To the extent that external expenses are not attributable to a specific project, they are allocated proportionally to each of the projects.

Current wording

We use external service providers to manufacture our product candidates and for the majority of the services performed in connection with the nonclinical and clinical development of our product candidates. Historically, we have used our internal research and development resources, including our employees and discovery infrastructure, across several projects and many of our costs have not been attributable to a specific project. Accordingly, we have not reported our internal research and development costs on a project-by-project basis. To the extent that external expenses are not attributable to a specific project, they are allocated proportionally to each of the projects.

Previous wording

The following table summarizes our research and development expenses for the three and six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our research and development expenses for the three and nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

At this time, due to the risks inherent in regulatory requirements and clinical development, we are unable to estimate with certainty the costs we will incur to support the commercialization of DAYBUE products, as well as the further development of our early-stage product candidates. Likewise, we are unable to determine with certainty the anticipated completion dates for our current research and development programs. Clinical development and regulatory approval timelines, probability of success, and development costs vary widely across our development programs. While our current development efforts are primarily focused on advancing the development of remlifanserin and other early-stage product candidates, we anticipate that we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to the scientific and clinical success of each product candidate, as well as an ongoing assessment of the commercial potential of each candidate and our financial position. We cannot forecast with any degree of certainty which product candidates will be subject to future collaborative or licensing arrangements, when such arrangements will be secured, if at all, and to what degree any such arrangements would affect our development plans and capital requirements. Similarly, we are unable to estimate with certainty the costs we will incur for post-marketing studies that we committed to conduct in connection with FDA approval of DAYBUE.

Current wording

At this time, due to the risks inherent in regulatory requirements and clinical development, we are unable to estimate with certainty the costs we will incur to support the commercialization of DAYBUE products, as well as the further development of our product candidates. Likewise, we are unable to determine with certainty the anticipated completion dates for our current research and development programs. Clinical development and regulatory approval timelines, probability of success, and development costs vary widely across our development programs. While our current development efforts are primarily focused on advancing the development of remlifanserin and early-stage product candidates, we anticipate that we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to the scientific and clinical success of each product candidate, as well as an ongoing assessment of the commercial potential of each candidate and our financial position. We cannot forecast with any degree of certainty which product candidates will be subject to future collaborative or licensing arrangements, when such arrangements will be secured, if at all, and to what degree any such arrangements would affect our development plans and capital requirements.

Previous wording

We expect our research and development expenses will continue to be substantial as we conduct studies pursuant to our PMRs and pursue the further development of remlifanserin and other early-stage product candidates. The lengthy process of completing clinical trials and supporting development activities and seeking regulatory approval for our product candidates requires the expenditure of substantial resources. Any failure by us or delay in completing clinical trials, or in obtaining regulatory approvals, could cause our research and development expenses to increase and, in turn, have a material adverse effect on our results of operations.

Current wording

We expect our research and development expenses will continue to be substantial as we conduct studies pursuant to our PMRs and pursue the further development of remlifanserin and early-stage product candidates. The lengthy process of completing clinical trials and supporting development activities and seeking regulatory approval for our product candidates requires the expenditure of substantial resources. Any failure by us or delay in completing clinical trials, or in obtaining regulatory approvals, could cause our research and development expenses to increase and, in turn, have a material adverse effect on our results of operations.

Previous wording

Net product sales, comprised of NUPLAZID and DAYBUE products, were $308.0 million and $264.6 million for the three months ended June 30, 2026 and 2025, respectively.

Current wording

Net product sales, comprised of NUPLAZID and DAYBUE products, were $342.3 million and $278.6 million for the three months ended September 30, 2026 and 2025, respectively.

Previous wording

Net product sales of NUPLAZID were $183.2 million and $168.5 million for the three months ended June 30, 2026 and 2025, respectively. The increase in net product sales of NUPLAZID of $14.7 million was due to the growth in NUPLAZID unit sales in 2026 compared to 2025. Net product sales of DAYBUE products were $124.8 million and $96.1 million for the three months ended June 30, 2026 and 2025, respectively. The increase in net product sales of DAYBUE products of $28.7 million was due to the growth in DAYBUE unit sales as well as a higher average net selling price of DAYBUE products in 2026 compared to 2025.

Current wording

Net product sales of NUPLAZID were $202.2 million and $177.5 million for the three months ended September 30, 2026 and 2025, respectively. The increase in net product sales of NUPLAZID of $24.7 million was primarily due to the growth in NUPLAZID unit sales in 2026 compared to 2025. Net product sales of DAYBUE products were $140.1 million and $101.1 million for the three months ended September 30, 2026 and 2025, respectively. The increase in net product sales of DAYBUE products of $39.0 million was primarily due to the growth in DAYBUE unit sales in 2026 compared to 2025.

Previous wording

Cost of product sales was $28.3 million and $20.7 million for the three months ended June 30, 2026 and 2025, respectively, or approximately 9% and 8% of net product sales, respectively. Cost of product sales as a percentage of net product sales remained relatively flat during the three months ended June 30, 2026 as compared to the same period of 2025

Current wording

Cost of product sales was $35.1 million and $21.6 million for the three months ended September 30, 2026 and 2025, respectively, or approximately 10% and 8% of net product sales, respectively. The increase in cost of product sales as a percentage of net product sales during the three months ended September 30, 2026 as compared to the same period of 2025 was primarily due to a higher proportion of DAYBUE sales in the current period as DAYBUE has a higher cost of product sales percentage than NUPLAZID.

Previous wording

Research and development expenses increased to $81.6 million for the three months ended June 30, 2026 from $78.0 million for the three months ended June 30, 2025. The increase in research and development expenses was primarily related to increased expenditures for remlifanserin and ACP-211, offset by reduced expenditures for ending studies that took place in 2025.

Current wording

Research and development expenses decreased to $76.3 million for the three months ended September 30, 2026 from $87.8 million for the three months ended September 30, 2025. The decrease in research and development expenses was primarily related to reduced expenditures for ending studies that took place in 2025, offset by increased expenditures for remlifanserin and ACP-211.

Previous wording

Selling, general and administrative expenses increased to $160.3 million for the three months ended June 30, 2026 from $133.5 million for the three months ended June 30, 2025. The increase in selling, general and administrative expenses was primarily driven by increased expenditures for DAYBUE products and NUPLAZID in the U.S., including the recent expansion of the DAYBUE and NUPLAZID teams.

Current wording

Selling, general and administrative expenses increased to $159.2 million for the three months ended September 30, 2026 from $133.4 million for the three months ended September 30, 2025. The increase in selling, general and administrative expenses was primarily driven by increased expenditures for DAYBUE products and NUPLAZID in the U.S., including the expansion of the DAYBUE and NUPLAZID teams.

Previous wording

Net product sales, comprised of NUPLAZID and DAYBUE products, were $576.0 million and $508.9 million for the six months ended June 30, 2026 and 2025, respectively.

Current wording

Net product sales, comprised of NUPLAZID and DAYBUE products, were $918.3 million and $787.5 million for the nine months ended September 30, 2026 and 2025, respectively.

Previous wording

Net product sales of NUPLAZID were $350.1 million and $328.2 million for the six months ended June 30, 2026 and 2025, respectively. The increase in net product sales of NUPLAZID of $21.9 million was mainly due to the growth in NUPLAZID unit sales in 2026 compared to 2025. Net product sales of DAYBUE products were $226.0 million and $180.7 million for the six months ended June 30, 2026 and 2025, respectively. The increase in net product sales of DAYBUE products of $45.3 million was primarily due to the growth in DAYBUE products unit sales.

Current wording

Net product sales of NUPLAZID were $552.2 million and $505.7 million for the nine months ended September 30, 2026 and 2025, respectively. The increase in net product sales of NUPLAZID of $46.5 million was mainly due to the growth in NUPLAZID unit sales in 2026 compared to 2025. Net product sales of DAYBUE products were $366.1 million and $281.8 million for the nine months ended September 30, 2026 and 2025, respectively. The increase in net product sales of DAYBUE products of $84.3 million was primarily due to the growth in DAYBUE products unit sales.

Previous wording

The following table provides a summary of activity with respect to our sales allowances and accruals for the six months ended June 30, 2026 (in thousands):

Current wording

The following table provides a summary of activity with respect to our sales allowances and accruals for the nine months ended September 30, 2026 (in thousands):

Previous wording

Cost of product sales was $53.1 million and $41.1 million for the six months ended June 30, 2026 and 2025, respectively, or approximately 9% and 8% of net product sales, respectively. Cost of product sales as a percentage of net product sales remained relatively flat during the six months ended June 30, 2026 as compared to the same period of 2025.

Current wording

Cost of product sales was $88.2 million and $62.8 million for the nine months ended September 30, 2026 and 2025, respectively, or approximately 10% and 8% of net product sales, respectively. The increase in cost of product sales as a percentage of net product sales during the nine months ended September 30, 2026 as compared to the same period of 2025 was primarily due to a higher proportion of DAYBUE sales in the current period as DAYBUE has a higher cost of product sales percentage than NUPLAZID, resulting in an unfavorable product mix impact on our overall gross margin.

Previous wording

Research and development expenses was $158.4 million and $156.2 million for the six months ended June 30, 2026 and 2025, respectively. The increase in research and development expenses was primarily related to increased expenditures for remlifanserin and ACP-211, offset by reduced expenditures for ending studies that took place in 2025.

Current wording

Research and development expenses was $234.7 million and $244.0 million for the nine months ended September 30, 2026 and 2025, respectively. The decrease in research and development expenses was primarily related to reduced expenditures for ending studies that took place in 2025, offset by increased expenditures for remlifanserin and ACP-211.

Previous wording

Selling, general and administrative expenses increased to $331.3 million for the six months ended June 30, 2026 from $259.9 million for the six months ended June 30, 2025. The increase in selling, general and administrative expenses was primarily driven by increased investments to support continued growth of NUPLAZID and DAYBUE products.

Current wording

Selling, general and administrative expenses increased to $490.5 million for the nine months ended September 30, 2026 from $393.3 million for the nine months ended September 30, 2025. The increase in selling, general and administrative expenses was primarily driven by increased investments to support continued growth of NUPLAZID and DAYBUE products.

Previous wording

the costs of preparing applications for regulatory approvals for DAYBUE products in jurisdictions other than the U.S., for NUPLAZID in additional indications other than PDP and for other product candidates, as well as the costs required to support review of such applications;

Current wording

the costs of preparing applications for regulatory approvals for DAYBUE products in jurisdictions other than the U.S. and for other product candidates, as well as the costs required to support review of such applications;

Previous wording

As discussed above, we have entered into various collaboration, licensing and merger agreements which generally include upfront license fees, development and commercial milestone payments upon achievement of certain clinical and commercial development and annual net sales milestones, as well as royalties calculated as a percentage of net product sales, with rates that vary by agreement.

Current wording

As discussed above, we have entered into various collaboration, licensing and merger agreements which generally include upfront license fees, development and commercial milestone payments upon achievement of certain clinical and commercial development and annual net sales milestones, as well as royalties calculated as a percentage of net product sales, with rates that vary by agreement. In connection with the EC marketing authorization of DAYBU in August 2026, we are required to make a milestone payment of $35.0 million to Neuren following the first commercial sale of DAYBU in the EU during the fourth quarter of 2026.

Previous wording

At June 30, 2026, we had $956.5 million in cash, cash equivalents, and investment securities, compared to $819.7 million at December 31, 2025. This $136.8 million increase was due to cash provided by operating activities. Net cash provided by operating activities totaled $134.8 million for the six months ended June 30, 2026 compared to $84.3 million for the six months ended June 30, 2025. This increase in cash provided by operations primarily resulted from the increase in product revenue partially offset by the increases in our research and development cost and selling, general and administrative cost.

Current wording

At September 30, 2026, we had $976.4 million in cash, cash equivalents, and investment securities, compared to $819.7 million at December 31, 2025. This $156.7 million increase was due to cash provided by operating activities. Net cash provided by operating activities totaled $146.3 million for the nine months ended September 30, 2026 compared to $158.6 million for the nine months ended September 30, 2025. This decrease in cash provided by operations primarily reflected the timing of working capital movements during the period.

Previous wording

Net cash provided by investing activities totaled $57.8 million for the six months ended June 30, 2026 compared to $167.3 million of net cash used in investing activities for the six months ended June 30, 2025. The increase in net cash provided by investing activities for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was primarily due to increased net sales and maturity of investment securities. Also during the six months ended June 30, 2025, there was a net payment of $98.8 million made to Neuren for the sale of the PRV and an annual net sales milestone which we did not have during the same period of 2026.

Current wording

Net cash used in investing activities totaled $28.4 million for the nine months ended September 30, 2026 compared to $246.7 million for the nine months ended September 30, 2025. The decrease in net cash used in investing activities for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025 was primarily due to increased net sales and maturity of investment securities. Also during the nine months ended September 30, 2025, there was a net payment of $98.8 million made to Neuren for the sale of the PRV and an annual net sales milestone which we did not have during the same period of 2026.

Previous wording

Net cash provided by financing activities decreased to $14.7 million for the six months ended June 30, 2026 compared to $17.8 million for the six months ended June 30, 2025. This decrease in net cash provided by financing activities for the six months ended June 30, 2026 was attributable primarily to a decrease in proceeds resulting from the exercise of employee stock options and awards.

Current wording

Net cash provided by financing activities decreased to $26.6 million for the nine months ended September 30, 2026 compared to $27.2 million for the nine months ended September 30, 2025. This decrease in net cash provided by financing activities for the nine months ended September 30, 2026 was attributable primarily to a decrease in proceeds resulting from the exercise of employee stock options and awards.