About ACADIA Pharmaceuticals

Acadia Pharmaceuticals Inc. (Acadia) operates as a biopharmaceutical company. The company focuses on the development and commercialization of innovative medicines that address unmet medical needs in central nervous system (CNS) disorders and rare diseases. The company has a portfolio of commercial stage products, in-development product opportunities, and research programs that are designed to address significant unmet needs in CNS disorders and rare diseases. In order to achieve significant long-term growth, the company will develop its portfolio, expand the company's pipeline of early- and late-stage programs through strategic business development, and invest in targeted internal research efforts. The company's commercial portfolio includes two products. In April 2016, the U.S. Food and Drug Administration (FDA) approved NUPLAZID for the treatment of hallucinations and delusions associated with PDP, which is the first and only drug approved in the United States for this condition. In March 2023, the FDA approved DAYBUE for the treatment of Rett syndrome, which is the first and only drug approved for this condition. DAYBUE became available for prescription in the United States in April 2023. NUPLAZID is a selective serotonin inverse agonist/antagonist, preferentially targeting 5-HT2A receptors with no appreciable affinity for dopaminergic, histaminergic, or muscarinic receptors. Through this novel mechanism, NUPLAZID demonstrated significant efficacy in reducing the hallucinations and delusions associated with PDP without negatively impacting motor function in the company's Phase 3 pivotal trial. NUPLAZID has the potential to avoid many of the debilitating side effects of existing antipsychotics, none of which are approved by the FDA for the treatment of PDP. The company holds worldwide commercialization rights to pimavanserin. In August 2018, the company acquired an exclusive North American license to develop and commercialize DAYBUE for Rett syndrome and other indications from Neuren Pharmaceuticals Limited (Neuren). Rett syndrome is a debilitating neurological disorder that occurs predominantly in females following apparently normal psychomotor development for the first six months of life. Rett syndrome also occurs in males, albeit far less frequently. Sometime between six to eighteen months of age, failure to reach normal developmental milestones is initially observed, which is then followed by a period of development regression with loss of purposeful hand use and spoken communication and inability to independently conduct activities of daily living. Symptoms also include seizures, hand movements or stereotypies, disorganized breathing patterns, scoliosis and sleep disturbances, among others. The FDA approval of DAYBUE for the treatment of Rett syndrome was based on the positive results from the company's pivotal Phase 3 LAVENDER study which demonstrated statistically significant and clinically meaning improvement over placebo for both co-primary endpoints in the study, as well as the key secondary endpoint of the study. In July 2023, the company expanded the 2018 licensing agreement with Neuren to acquire rights to trofinetide outside of North America and global rights to Neuren's development candidate NNZ-2591 in Rett syndrome and Fragile X syndrome. In addition to the treatment of hallucinations and delusions associated with the PDP, pimavanserin has the potential as a treatment of the negative symptoms of schizophrenia. The company is evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia in a Phase 3 clinical development program. The negative symptoms of schizophrenia have been associated with poor long-term outcomes and disability even when the positive symptoms are well-controlled, and today there are no FDA-approved therapies. In the fourth quarter of 2019, the company announced positive results from the company's pivotal ADVANCE study and in the third quarter of 2020, the company initiated a second pivotal study, ADVANCE-2. The Phase 3 program is evaluating the efficacy of pimavanserin in patients with predominantly negative symptoms of schizophrenia who have achieved adequate control of positive symptoms with their existing antipsychotic treatment. The company completed enrollment in ADVANCE-2 and expect that top-line results will be available in the first quarter of 2024. In June 2023, the company announced that it added a new Phase 3 development candidate to the company's rare disease portfolio, ACP-101 (intranasal carbetocin), for the treatment of hyperphagia (an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety) in Prader-Willi syndrome (PWS). The company acquired worldwide rights to develop and commercialize ACP-101 with the acquisition of Levo Therapeutics in June 2022. In November 2023, the company initiated the Phase 3 COMPASS PWS study evaluating the efficacy and safety of ACP-101 for the treatment of hyperphagia in PWS. In addition, in August 2022, the company announced that the company is developing an internally discovered new molecule, ACP-204, which builds upon the learnings of pimavanserin in the treatment of neuropsychiatric symptoms. The company completed a Phase 1 study of ACP-204 which demonstrated a favorable safety and tolerability profile, and supports its target product profile as a potential treatment for Alzheimer's disease psychosis (ADP). In November 2023, the company initiated a Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with ADP. ACP-204 is a new chemical entity for which the company holds the worldwide rights. In January 2022, the company entered into a license and collaboration agreement with Stoke Therapeutics, Inc. (Stoke) to discover, develop and commercialize novel RNA-based medicines for the potential treatment of severe and rare genetic neurodevelopmental diseases of the CNS. The collaboration includes SYNGAP1 syndrome, Rett syndrome (MECP2), and an undisclosed neurodevelopmental target. For the SYNGAP1 program, the two companies will jointly share global research, development and commercialization responsibilities and share 50/50 in all worldwide costs and future profits. For the Rett syndrome (MECP2) and the undisclosed neurodevelopmental program, Stoke will lead research and pre-clinical development activities, while the company will lead clinical development and commercialization activities. The company owns or has rights to various trademarks, copyrights and trade names used in the company's business, including Acadia, NUPLAZID and DAYBUE. The company's logos and trademarks are the property of Acadia. Strategy The company's strategy is to identify, develop and commercialize innovative therapies that address unmet medical needs in CNS disorders and rare diseases. The key elements of the company's strategy are to build on the strong commercialization of DAYBUE for the treatment of patients with Rett syndrome in the United States; maximize the successful commercialization of NUPLAZID for Parkinson's disease psychosis in the United States; advance the company's late-stage opportunities to drive further growth; deliver DAYBUE to the international market for the treatment of patients with Rett syndrome; and develop the company's early-stage programs and other business development opportunities. Pipeline NUPLAZID (pimavanserin) Pimavanserin is a chemical entity that the company discovered and that was approved by the FDA in April 2016 for the treatment of hallucinations and delusions associated with PDP. It is the only drug approved in the United States for this condition and is marketed under the tradename NUPLAZID in the United States. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting the 5-HT2A receptor, a key serotonin receptor that plays an important role in psychosis. Through this novel mechanism, NUPLAZID demonstrated significant efficacy in reducing the hallucinations and delusions associated with PDP without negatively impacting motor function in the company's Phase 3 pivotal trial. NUPLAZID has the potential to avoid many of the debilitating side effects of existing antipsychotics, none of which are approved by the FDA in the treatment of PDP. The company holds worldwide commercialization rights to NUPLAZID for all indications and have established a broad patent portfolio, which includes numerous issued patents in the United States, Europe, and several additional countries. NUPLAZID is available in 34 mg capsule and 10 mg tablet dosage forms. NUPLAZID as a Treatment for Parkinson's Disease Psychosis As the first and only drug approved by the FDA for the treatment of hallucinations and delusions associated with PDP, NUPLAZID provides an innovative approach to the treatment of PDP without compromising motor control and potentially avoiding many of the debilitating side effects of existing antipsychotics. In connection with the FDA approval of NUPLAZID, the company has agreed to four post-marketing commitments. Three of the four commitments have been fulfilled within the agreed upon timelines. The fourth commitment, a randomized, placebo-controlled eight-week study or studies in predominantly frail and elderly patients that would add to the NUPLAZID safety database by exposing an aggregate of at least 500 patients to NUPLAZID, has been completed and the company is awaiting FDA's acknowledgement and acceptance. Pimavanserin as a Treatment for the Negative Symptoms of Schizophrenia In November 2016, the company announced that the company initiated ADVANCE, a Phase 2 study to evaluate pimavanserin for adjunctive treatment in patients with negative symptoms of schizophrenia. ADVANCE was a Phase 2, 26-week, randomized, double-blind, placebo-controlled, multi-center, international study designed to examine the efficacy and safety of pimavanserin in patients with schizophrenia who have predominant negative symptoms while on a stable background antipsychotic therapy. 403 patients were randomized to receive once-daily pimavanserin (n=201) or placebo (n=202) as an adjunct treatment to their ongoing antipsychotic in a flexible dosing regimen. The starting daily dose of 20 mg of pimavanserin at baseline could have been adjusted to 34 mg or 10 mg during the first eight weeks of treatment. 53.8% of patients who were randomized to receive pimavanserin completed the trial on 34 mg, 44.7% on 20 mg, and 1.5% on 10 mg. The primary endpoint of the study was the change from baseline to week 26 on the Negative Symptom Assessment-16 (NSA-16) total score. In November 2019, the company announced positive top-line results from the ADVANCE study. In this study, pimavanserin demonstrated a statistically significant improvement on the study's primary endpoint, the change from baseline to week 26 on the NSA-16 total score, compared to placebo (p=0.043). A greater improvement in the NSA-16 total score compared to placebo was observed in patients who received the highest pimavanserin dose of 34 mg (n=107; unadjusted p=0.0065). Pimavanserin did not separate from placebo on the key secondary endpoint, the Personal and Social Performance (PSP) scale. In the third quarter of 2020, the company initiated a second pivotal study, ADVANCE-2. The Phase 3 study will evaluate the efficacy of pimavanserin 34 mg once daily compared to placebo in approximately 454 patients with predominantly negative symptoms of schizophrenia who have achieved adequate control of positive symptoms with their existing antipsychotic treatment. The company anticipates announcing top-line results from the Phase 3 ADVANCE-2 study in the first quarter of 2024. DAYBUE (trofinetide) as a Treatment for Rett Syndrome Trofinetide is a novel synthetic analog of the amino-terminal tripeptide of insulin-like growth factor 1 (IGF-1) designed to treat the core symptoms of Rett syndrome by reducing neuroinflammation and supporting synaptic function. Trofinetide has been granted FDA Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Designation in Europe. In March 2023, the FDA approved DAYBUE for the treatment of Rett syndrome, which is the first and only drug approved for this condition. In addition, the company was granted a Rare Pediatric Disease Priority Review Voucher (PRV) following the FDA approval of DAYBUE. DAYBUE became available for prescription in the United States in April 2023. In connection with the FDA approval of DAYBUE, the company is required to conduct post-marketing work, including a clinical study of renal impairment in healthy volunteers, nonclinical carcinogenicity studies, and nonclinical in vitro drug interaction studies. ACP-101 as a Treatment for Prader-Willi syndrome Carbetocin nasal spray (ACP-101) is an investigational drug being developed for the treatment of hyperphagia in PWS. Carbetocin has improved drug qualities relative to oxytocin, including an extended half-life and greater specificity for the oxytocin receptor compared to vasopressin receptors which could provide meaningful efficacy with an attractive safety profile in patients with PWS. For the treatment of PWS specifically, a central nervous system disorder, an intranasal formulation of carbetocin was developed, which provides direct delivery of the drug to the brain, greatly reducing systemic exposure and the potential for side effects. The company acquired Levo Therapeutics and worldwide rights to carbetocin nasal spray in June 2022. Carbetocin nasal spray has been granted Orphan Drug, Fast Track, and Rare Pediatric Disease designations by the FDA. In the fourth quarter of 2023, the company initiated the Phase 3 COMPASS PWS study evaluating the efficacy and safety of ACP-101 for the treatment of hyperphagia in PWS. COMPASS PWS is a 12-week, double-blind, randomized, placebo-controlled global Phase 3 trial evaluating the efficacy and safety of carbetocin nasal spray 3.2 mg three times daily (TID) in approximately 170 children and adults aged five to 30 years with PWS. The primary efficacy endpoint of the study is change from baseline to week 12 on the hyperphagia questionnaire for clinical trials (HQ-CT) score, a caregiver assessment for hyperphagia-related behaviors. Participants who complete the Phase 3 study will be eligible to enroll in a long-term, open-label extension study designed to investigate the safety and tolerability of long-term treatment with ACP-101. ACP-204 as a Treatment for Alzheimer's Disease Psychosis ACP-204 is a new chemical entity which is designed to leverage the learnings from pimavanserin. For several years, the company has sought to build upon the company's pimavanserin franchise by investigating and developing other molecules focused on the serotonergic system. Virtually all of the antipsychotics on the market today are thought to work predominantly through blocking dopamine and in particular, the dopamine D2 receptor. Pimavanserin is thought to work entirely through serotonin, which can provide a very different and favorable safety and tolerability profile. Specifically with ACP-204, the company may have an opportunity to maximize the efficacy potential, while reducing the risk of QT prolongation. The company completed Phase 1 study of ACP-204 which demonstrated a favorable safety and tolerability profile, and supports its target product profile as a potential treatment for ADP. In the fourth quarter of 2023, the company initiated a Phase 2 study of ACP-204 for the treatment of hallucinations and delusions associated with ADP. The Phase 2 study is part of a seamless Phase 2 / Phase 3 program that includes three studies: a single Phase 2 study and two Phase 3 studies which have almost identical design. The Phase 2 study is a global, multi-center, randomized, double-blind, placebo-controlled trial that will enroll approximately 318 patients and evaluate ACP-204 30 mg and 60 mg doses compared to placebo. The primary endpoint is change from baseline to week 6 on the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score. The clinical trial sites will enroll seamlessly from Phase 2 into Phase 3. Each of the planned Phase 3 studies will enroll approximately 378 patients with ADP. Patients who complete the study will have the option of participating in a long-term open-label extension study. Antisense Oligonucleotide (ASO) Programs In January 2022, the company entered into a collaboration with Stoke to discover, develop and commercialize novel RNA-based medicines for the potential treatment of severe and rare genetic neurodevelopmental diseases of the CNS. The collaboration includes SYNGAP1, MECP2 (Rett syndrome) and an undisclosed CNS target of mutual interest. The programs are in various stages of pre-clinical development. Intellectual Property The company holds 59 issued U.S. patents and a significant number of related issued foreign patents. The company has also exclusively licensed rights to an additional 35 issued U.S. patents, and a number of related foreign patents. Patents and other proprietary intellectual property rights are an essential element of the company's business. The company's strategy is to file patent applications in the United States and any other country that represents an important potential commercial market to the company. Pimavanserin The company holds 36 U.S. patents that relate to pimavanserin, NUPLAZID and methods of use of pimavanserin. Fifteen of these are Orange Book-listed patents that relate to pimavanserin, NUPLAZID and the company's approved indication, and cover the general formula of the compound, the composition of matter, with claims specifically directed to pimavanserin and salts thereof, the specific polymorph form of pimavanserin, the approved formulations, and the use thereof for treating the company's approved indication. The composition of matter patent covering pimavanserin and salts thereof has an expiration date in 2030, including a patent term extension approved by the U.S. Patent and Trademark Office. The patents covering the polymorph form and the use of pimavanserin or NUPLAZID for the company's approved indication are set to expire between 2024 and 2028. These patent terms include adjustments made by the U.S. Patent and Trademark Office, but not extensions. In the United States, under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as 'Hatch-Waxman,' the company is permitted to extend the term of one U.S. patent for pimavanserin or the use thereof. Patent terms may be subject to change not only due to potential patent term extensions but also to any terminal disclaimer that reduces patent term, as well as other factors. Because the U.S. patent laws and judicial interpretations thereof change, modifications or new interpretations of the laws may impact the company's patent terms. The remaining 21 U.S. patents relating to pimavanserin that have been issued to the company covers methods of use of pimavanserin for, among other things, treating ADP, Alzheimer's disease indications, schizophrenia, bipolar disorder, Lewy body dementia, sleep disorders, hallucinations and delusions, other indications and methods of manufacturing pimavanserin. The company also has a significant number of related issued foreign patents that specifically cover pimavanserin and polymorphs thereof in Europe and Asia, as well as in Australia, Canada, Mexico and other countries. The company continues to file and prosecute patent applications directed to pimavanserin, formulations of pimavanserin, methods of manufacturing, and to methods of treating various diseases using pimavanserin, either alone or in combination with other agents, worldwide. For example, in late 2019 and in 2020, the company obtained and listed in the Orange Book six additional U.S. issued patents, two patents directed to method of use for the company's 10 mg tablet, expiring in 2037, and four patents directed to the company's 34 mg capsule formulation, each expiring in 2038. Trofinetide The company holds the exclusive licenses to 8 U.S. patents from Neuren Pharmaceuticals that relate to trofinetide, methods of manufacturing and methods of use of trofinetide. Two of the U.S. patents are listed in the Orange Book, including a patent claiming the use of trofinetide for treating Rett syndrome. The use patent for treating Rett syndrome has an expiration date in 2032. Subject to a patent term extension request, the expiration date of such patent may be extended to January 2036. Under the license agreement with Neuren, the company continues to file and prosecute patent applications directed to trofinetide, formulations of trofinetide, methods of manufacturing and methods of treating Rett syndrome using trofinetide. Government Regulation The company's business activities, including the manufacturing and marketing of NUPLAZID, DAYBUE and the company's potential products and the company's ongoing research and development activities, are subject to extensive regulation by numerous governmental authorities in the United States and other countries. Before marketing in the United States, any new drug developed by the company must undergo rigorous preclinical testing, clinical trials and an extensive regulatory clearance process implemented by the FDA under the Federal Food, Drug, and Cosmetic Act, as amended. In addition, the company is subject to state and federal laws, including, among others, anti-kickback laws, false claims laws, data privacy and security laws, and transparency laws that restrict certain business practices in the pharmaceutical industry. Before commencing clinical investigations in humans, the company or its collaborators must submit an Investigational New Drug Application (IND), to the FDA. Additionally, the manufacture of the company's drug product must be done in accordance with current good manufacturing practices (cGMPs). The company and its collaborators and contract manufacturers also are required to comply with the applicable FDA GMP regulations. If a product is approved, the company must also comply with post-marketing requirements, including, but not limited to, compliance with advertising and promotion laws enforced by various government agencies, including the FDA's Office of Prescription Drug Promotion, and through such laws as federal and state anti-fraud and abuse laws, including anti-kickback and false claims laws, healthcare information privacy and security laws, post-marketing safety surveillance, and disclosure of payments or other transfers of value to healthcare professionals and entities. In addition, the company is subject to other federal and state regulation including, for example, the implementation of corporate compliance programs. Among the provisions of the ACA of importance to NUPLAZID, DAYBUE and the company's product candidates are: (i) increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations; (ii) established an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs; (iii) expanded the availability of lower pricing under the 340B drug pricing program by adding new entities to the program; (iv) increased the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price (AMP); (v) expanded the eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals, thereby potentially increasing manufacturers' Medicaid rebate liability; (vi) created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and (vii) established a Center for Medicare and Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending. Manufacturing and Distribution The company licensed worldwide intellectual property rights related to pimavanserin in certain indications to Acadia Pharmaceuticals GmbH, the company's wholly-owned Swiss subsidiary (Acadia GmbH). The company's active pharmaceutical ingredient (API) has been manufactured in Switzerland for over 10 years and the company anticipates continuing to manufacture in Switzerland. Acadia GmbH manages the worldwide supply chain of the company's pimavanserin API, and maintains sufficient materials to manufacture the company's API. Acadia GmbH has contracted with Siegfried AG (Siegfried), to manufacture the company's API to be used in NUPLAZID for commercial sale. Under the manufacturing agreement, Acadia GmbH has agreed to purchase from Siegfried specified percentages of the company's commercial requirements of API for the United States and Europe. The company has contracted with Patheon Pharmaceuticals Inc. (Patheon), to manufacture NUPLAZID 10 mg tablet and 34 mg capsule drug product for commercial use in the United States. The company has also contracted with a second contract manufacturing organization to manufacture NUPLAZID 34 mg drug product for commercial use in the United States. Under the manufacturing agreement with Patheon, the company has agreed to purchase from Patheon a specified percentage of the company's commercial requirements of NUPLAZID for the United States. The company sells NUPLAZID to a limited number of specialty pharmacies (SPs), and specialty distributors (SDs), which the company collectively refers to as the company's customers. SPs subsequently dispense NUPLAZID to patients based on the fulfillment of a prescription and SDs subsequently sell NUPLAZID to government facilities, long-term care pharmacies, and in-patient hospital pharmacies. Four of such customers, each based in the United States, accounted for approximately 73% of the company's NUPLAZID product revenue and 56% of the company's total product revenue for the year ended December 31, 2023. The company has retained third-party service providers to perform a variety of functions related to the distribution of NUPLAZID, including warehousing, customer service, order-taking, invoicing, collections, and shipment and returns processing. The company has contracted with manufacturers to produce supplies of trofinetide to support the development program and for commercial sale. The company has contracted with Corden Pharma Bergamo S.p.A. (Corden), to manufacture the API for trofinetide products. Under the manufacturing agreement with Corden, the company has agreed to purchase from Corden the API for trofinetide products at specified price per volume. The company and Corden may also agree in the future on additional services under the manufacturing agreement. The term of the manufacturing agreement will end in November 2027 and will automatically renew for subsequent two-year terms unless either party provides timely notice of its intent not to renew, or unless the manufacturing agreement is terminated early pursuant to its terms. The company also has contracted with F.I.S. Fabbrica Italiana Sintetici S.p.A. (FIS) to manufacture the API for trofinetide products. Under the manufacturing agreement, the company has the right to purchase from FIS the API for the trofinetide products at a specified price per volume. The parties may also agree in the future on additional services under the manufacturing agreement with respect to commercial testing and other manufacturing services. The term of the manufacturing agreement will end in December 2024 and will automatically renew for subsequent two-year terms unless either party provides timely notice of its intent not to renew, or unless the manufacturing agreement is terminated earlier pursuant to its terms. Under the manufacturing agreement with Patheon described above, the company also has the right to purchase trofinetide products for commercial use. In addition, the company has contracted with CoreRx Inc. (CoreRx) to manufacture trofinetide products for commercial use. The company and CoreRx may also agree in the future on additional services under the agreement. The term of the agreement will end in March 2028 and will automatically renew for subsequent two-year terms unless either party provides timely notice of its intent not to renew, or unless the agreement is terminated early pursuant to its terms. The company sells DAYBUE to a single wholesale distributor which performs a variety of functions related to the distribution of DAYBUE, including warehousing, customer service, order-taking, shipment and returns processing. Sales and Marketing The company has the U.S. sales specialists that are focused on promoting NUPLAZID to physicians who treat PDP patients, including neurologists, psychiatrists and long-term care physicians. This sales force is supported by an experienced sales leadership team. The company's experienced commercial team is consisted of experienced professionals in marketing, key account management, patient access services, commercial operations, and sales force planning and management. In addition, the company's commercial infrastructure includes capabilities in manufacturing, health outcomes, medical affairs, quality control, and compliance. The company launched NUPLAZID in May 2016, and the company's focus is to continue to establish NUPLAZID as the standard of care for patients with PDP. In order to help the company achieves this goal, the company is continuing to increase awareness of NUPLAZID's benefits in PDP with a prescriber and patient education campaign consisting of key opinion leader speaker programs, attendance at medical meetings, digital outreach, multimedia campaigns, and direct-to-patient programs. In addition, the company has the U.S. sales specialists that are focused on promoting DAYBUE to physicians who treat Rett syndrome patients, including those at Centers of Excellence, high volume institutions and in the community setting. The sales force is supported by an experienced sales leadership team. The company's experienced commercial team is consisted of rare disease field-based specialists, patient access services, commercial operations, and sales force planning and management. In addition, the company's commercial infrastructure includes capabilities in manufacturing, health outcomes, medical affairs, quality control, and compliance. The company launched DAYBUE in April 2023, and the company's focus is to continue to establish DAYBUE as the standard of care for patients with Rett syndrome. In order to help the company achieves this goal, the company is continuing to increase awareness of DAYBUE's benefits in Rett syndrome with a prescriber and patient education campaign consisting of key opinion leader speaker programs, attendance at medical meetings, digital outreach, and multimedia campaigns. The company also has support services, including the Acadia Connect hub for physicians, patients and their families that provide broad resources to help with access, reimbursement and the continual clinical support to help patients start and stay on therapy. For healthcare providers and practices, Acadia Connect provides access and coverage support services, information on appropriate financial assistance options for eligible patients, and coordination of medication delivery to patients through the company's specialty pharmacy. In selected markets outside of the United States in which DAYBUE may be approved, if any, the company may choose to commercialize DAYBUE independently or by establishing one or more strategic alliances. Research and Development Expenses The company's research and development expenses were $351.6 million in 2023. History ACADIA Pharmaceuticals Inc. was founded in 1993. The company was incorporated in Vermont in 1993 and was reincorporated in Delaware in 1997.