1. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following upcoming investor conferences:

    Citi's 16th Annual BioPharma Virtual Conference
    Fireside Chat Presentation: Friday, September 10, 2021 at 11:35 a.m. Eastern Time

    Morgan Stanley Virtual 19th Annual Global Healthcare Conference
    Fireside Chat Presentation: Monday, September 13, 2021 at 11:45 a.m. Eastern Time

    2021 Cantor Virtual Global Healthcare Conference
    Fireside Chat Presentation: Monday, September 27, 2021 at 1:20 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following upcoming investor conferences:

    Citi's 16th Annual BioPharma Virtual Conference

    Fireside Chat Presentation: Friday, September 10, 2021 at 11:35 a.m. Eastern Time

    Morgan Stanley Virtual 19th Annual Global Healthcare Conference

    Fireside Chat Presentation: Monday, September 13, 2021 at 11:45 a.m. Eastern Time

    2021 Cantor Virtual Global Healthcare Conference

    Fireside Chat Presentation: Monday, September 27, 2021 at 1:20 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn and Twitter.

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  2. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that Elena Ridloff, Executive Vice President and Chief Financial Officer (CFO), will be leaving the company effective September 10, 2021 to join another biopharmaceutical company. Mark Schneyer, Senior Vice President, Business Development and Chief Business Officer, will serve as Acadia's interim Chief Financial Officer. The company is conducting a formal search for a new CFO.

    "On behalf of all of us at Acadia, I want to thank Elena for her leadership and contributions which played an important role in supporting Acadia's growth and long-term business strategy, and we wish her well in her future endeavors," said Steve Davis, Chief Executive Officer.

    "I want to thank my colleagues at…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that Elena Ridloff, Executive Vice President and Chief Financial Officer (CFO), will be leaving the company effective September 10, 2021 to join another biopharmaceutical company. Mark Schneyer, Senior Vice President, Business Development and Chief Business Officer, will serve as Acadia's interim Chief Financial Officer. The company is conducting a formal search for a new CFO.

    "On behalf of all of us at Acadia, I want to thank Elena for her leadership and contributions which played an important role in supporting Acadia's growth and long-term business strategy, and we wish her well in her future endeavors," said Steve Davis, Chief Executive Officer.

    "I want to thank my colleagues at Acadia for their partnership in driving growth of the pimavanserin franchise and advancing important therapies in our pipeline," said Ms. Ridloff. "I'm confident the experienced Acadia team will continue to deliver on its mission for patients."

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn and Twitter.

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  3. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Canaccord Genuity 41st Annual Growth Conference on Thursday, August 12, 2021, at 3:00 p.m. Eastern Time.

    The conference will be held virtually. A live webcast of Acadia's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through September 12, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Canaccord Genuity 41st Annual Growth Conference on Thursday, August 12, 2021, at 3:00 p.m. Eastern Time.

    The conference will be held virtually. A live webcast of Acadia's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through September 12, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn and Twitter.

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  4. - 2Q21 net sales of $115.2 million, a 5% increase over 2Q20

    - Fiscal year 2021 revenue guidance reduced to $480 to $515 million

    - Type A meeting held with FDA regarding DRP; Acadia will continue discussion with FDA in another meeting later this year

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), today announced its financial results for the second quarter ended June 30, 2021.

    "NUPLAZID performed well in the second quarter of 2021, highlighted by our ability to drive growth while still navigating the continued impact from the pandemic," said Steve Davis, Chief Executive Officer. "We recently completed a Type A meeting with the FDA regarding pimavanserin for dementia-related psychosis and plan to continue our engagement in another meeting with…

    - 2Q21 net sales of $115.2 million, a 5% increase over 2Q20

    - Fiscal year 2021 revenue guidance reduced to $480 to $515 million

    - Type A meeting held with FDA regarding DRP; Acadia will continue discussion with FDA in another meeting later this year

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), today announced its financial results for the second quarter ended June 30, 2021.

    "NUPLAZID performed well in the second quarter of 2021, highlighted by our ability to drive growth while still navigating the continued impact from the pandemic," said Steve Davis, Chief Executive Officer. "We recently completed a Type A meeting with the FDA regarding pimavanserin for dementia-related psychosis and plan to continue our engagement in another meeting with the FDA later this year to further discuss potential paths to approval. Looking ahead, we plan to announce top-line results by the end of the year from our Phase 3 study in Rett syndrome and our proof-of-concept Phase 2 study in postoperative pain."

    Company Updates

    • Completed a Type A End of Review meeting regarding the FDA's complete response letter (CRL) for the sNDA for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). At the meeting, the FDA reiterated their stated position in the CRL, that pimavanserin should be studied by individual subgroups of dementia, and advised that the best path forward is to conduct an additional clinical study in each of the subgroups for which we seek approval. However, the FDA also indicated that they are open to having another meeting to discuss additional analyses from the HARMONY and -019 studies in support of a potential resubmission without an additional clinical study.
    • The New England Journal of Medicine published the positive results from the Phase 3 HARMONY study evaluating pimavanserin in patients with dementia-related psychosis in July 2021.
    • Results from an open-label extension safety study with pimavanserin supporting sustained response in Parkinson's disease psychosis patients was published online in the June 2021 issue of Parkinsonism and Related Disorders.
    • Completed enrollment of the Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome, with top-line results expected in the fourth quarter of 2021.
    • Initiated a Phase 2 study of ACP-044 for pain associated with osteoarthritis in the second quarter of 2021.
    • Top-line results from the Phase 2 study of ACP-044 for the treatment of postoperative pain following bunionectomy surgery are expected in the fourth quarter of 2021.

    Financial Results

    Revenue

    Net sales of NUPLAZID® (pimavanserin) were $115.2 million for the three months ended June 30, 2021, an increase of 5% as compared to $110.1 million reported for the three months ended June 30, 2020. For the six months ended June 30, 2021 and 2020, Acadia reported net product sales of $221.8 million and $200.2 million, respectively.

    Research and Development

    Research and development expenses for the three months ended June 30, 2021 were $56.9 million, compared to $64.3 million for the same period of 2020. The decrease in the three month period ending June 2021 compared to June 2020 was largely due to the cessation of development costs of pimavanserin for major depressive disorder and lower development costs for DRP. For the six months ended June 30, 2021 and 2020, research and development expenses were $113.9 million and $136.9 million. The decrease for the six month period ending June 2021 compared to June 2020 was largely due to lower development costs of pimavanserin and trofinetide, partially offset by increased development costs for ACP-044.

    Selling, General and Administrative

    Selling, general and administrative expenses for the three months ended June 30, 2021 were $96.8 million, compared to $84.3 million for the same period of 2020. The increase for the three month period ending June 2021 compared to June 2020 was primarily due to increased costs associated with advertising and promotion, corporate support functions and stock-based compensation. For the six months ended June 30, 2021 and 2020, selling, general and administrative expenses were $208.5 million and $186.3 million, respectively. The increase for the six month period ending June 2021 compared to June 2020 was primarily due to increased costs associated with advertising, promotion and preparations for the potential DRP launch.

    Net Loss

    For the three months ended June 30, 2021, Acadia reported a net loss of $43.9 million, or $0.27 per common share, compared to a net loss of $42.1 million, or $0.27 per common share, for the same period in 2020. The net losses for the three months ended June 30, 2021 and 2020 included $22.0 million and $19.5 million, respectively, of non-cash stock-based compensation expense. For the six months ended June 30, 2021, Acadia reported a net loss of $110.3 million, or $0.69 per common share, compared to a net loss of $130.2 million, or $0.83 per common share, for the same period in 2020. The net losses for the six months ended June 30, 2021 and 2020 included $35.2 million and $41.9 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At June 30, 2021, Acadia's cash, cash equivalents, and investment securities totaled $556.9 million, compared to $632.0 million at December 31, 2020.

    2021 Financial Guidance

    • NUPLAZID net sales guidance is decreased to $480 to $515 million from the previous range of $510 to $550 million as a result of the continued impact of the pandemic with fewer Parkinson's disease patient office visits and lower occupancy rates at long-term care facilities, as well as a revised gross-to-net expectation of approximately 20% compared to prior expectation of high teens.
    • GAAP R&D is decreased to $250 to $270 million from the previous range of $280 to $300 million. Current R&D guidance includes approximately $25 million of stock-based compensation expense.
    • GAAP SG&A guidance is reiterated at $385 to $415 million. Current SG&A guidance includes approximately $50 million of stock-based compensation expense.

    Conference Call and Webcast Information

    Acadia management will review its second quarter financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 8065926). A telephone replay of the conference call may be accessed through August 18, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 8065926). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there until September 1, 2021.

    About NUPLAZID® (pimavanserin)

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn and Twitter.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2021 NUPLAZID net sales for Parkinson's disease psychosis and certain expense line items. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2021, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

     

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

     

     

    Three Months Ended June 30,

     

     

    Six Months Ended June 30,

     

     

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     

    Revenues

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    115,221

     

     

    $

    110,103

     

     

    $

    221,775

     

     

    $

    200,171

     

    Total revenues

     

     

    115,221

     

     

     

    110,103

     

     

     

    221,775

     

     

     

    200,171

     

    Operating expenses

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties (1)

     

     

    5,206

     

     

     

    5,474

     

     

     

    9,898

     

     

     

    10,448

     

    Research and development (1)

     

     

    56,935

     

     

     

    64,295

     

     

     

    113,908

     

     

     

    136,931

     

    Selling, general and administrative (1)

     

     

    96,789

     

     

     

    84,344

     

     

     

    208,450

     

     

     

    186,317

     

    Total operating expenses

     

     

    158,930

     

     

     

    154,113

     

     

     

    332,256

     

     

     

    333,696

     

    Loss from operations

     

     

    (43,709

    )

     

     

    (44,010

    )

     

     

    (110,481

    )

     

     

    (133,525

    )

    Interest income, net

     

     

    133

     

     

     

    1,825

     

     

     

    333

     

     

     

    4,814

     

    Other income (expense)

     

     

    178

     

     

     

    437

     

     

     

    323

     

     

     

    (1,060

    )

    Loss before income taxes

     

     

    (43,398

    )

     

     

    (41,748

    )

     

     

    (109,825

    )

     

     

    (129,771

    )

    Income tax expense

     

     

    473

     

     

     

    393

     

     

     

    494

     

     

     

    393

     

    Net loss

     

    $

    (43,871

    )

     

    $

    (42,141

    )

     

    $

    (110,319

    )

     

    $

    (130,164

    )

    Net loss per common share, basic and diluted

     

    $

    (0.27

    )

     

    $

    (0.27

    )

     

    $

    (0.69

    )

     

    $

    (0.83

    )

    Weighted average common shares outstanding, basic and diluted

     

     

    160,421

     

     

     

    156,535

     

     

     

    160,217

     

     

     

    155,951

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    (1) Includes the following stock-based compensation expense

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties

     

    $

    423

     

     

    $

    743

     

     

    $

    586

     

     

    $

    1,592

     

    Research and development

     

    $

    7,319

     

     

    $

    7,235

     

     

    $

    12,149

     

     

    $

    15,692

     

    Selling, general and administrative

     

    $

    14,263

     

     

    $

    11,529

     

     

    $

    22,454

     

     

    $

    24,571

     

     

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

    June 30,

    2021

     

     

    December 31,

    2020

     

     

     

    (unaudited)

     

     

     

     

     

    Assets

     

     

     

     

     

     

     

     

    Cash, cash equivalents and investment securities

     

    $

    556,918

     

     

    $

    631,958

     

    Accounts receivable, net

     

     

    51,367

     

     

     

    48,247

     

    Interest and other receivables

     

     

    453

     

     

     

    2,035

     

    Inventory

     

     

    10,786

     

     

     

    9,682

     

    Prepaid expenses

     

     

    26,206

     

     

     

    25,694

     

    Total current assets

     

     

    645,730

     

     

     

    717,616

     

    Property and equipment, net

     

     

    9,197

     

     

     

    9,161

     

    Operating lease right-of-use assets

     

     

    61,371

     

     

     

    47,283

     

    Intangible assets, net

     

     

    369

     

     

     

    1,108

     

    Restricted cash

     

     

    5,770

     

     

     

    5,770

     

    Other assets

     

     

    1,992

     

     

     

    1,678

     

    Total assets

     

    $

    724,429

     

     

    $

    782,616

     

    Liabilities and stockholders' equity

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    9,065

     

     

    $

    8,493

     

    Accrued liabilities

     

     

    86,263

     

     

     

    97,474

     

    Total current liabilities

     

     

    95,328

     

     

     

    105,967

     

    Operating lease liabilities

     

     

    59,134

     

     

     

    44,460

     

    Other long-term liabilities

     

     

    5,129

     

     

     

    5,180

     

    Total liabilities

     

     

    159,591

     

     

     

    155,607

     

    Total stockholders' equity

     

     

    564,838

     

     

     

    627,009

     

    Total liabilities and stockholders' equity

     

    $

    724,429

     

     

    $

    782,616

     

     

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  5. - Pimavanserin met the primary endpoint of reduced risk of relapse of psychosis by 2.8 fold compared to placebo

    - Pimavanserin met the secondary endpoint of significantly reducing trial discontinuation for any reason by 2.2 fold

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that the New England Journal of Medicine published results from the Phase 3 HARMONY study, an international, double-blind, placebo-controlled relapse prevention trial in 392 patients evaluating pimavanserin as an investigational treatment in patients with hallucinations and delusions associated with dementia-related psychosis (DRP). The study included patients across five subgroups of dementia: Alzheimer's disease, dementia with Lewy bodies, frontotemporal…

    - Pimavanserin met the primary endpoint of reduced risk of relapse of psychosis by 2.8 fold compared to placebo

    - Pimavanserin met the secondary endpoint of significantly reducing trial discontinuation for any reason by 2.2 fold

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that the New England Journal of Medicine published results from the Phase 3 HARMONY study, an international, double-blind, placebo-controlled relapse prevention trial in 392 patients evaluating pimavanserin as an investigational treatment in patients with hallucinations and delusions associated with dementia-related psychosis (DRP). The study included patients across five subgroups of dementia: Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease dementia, and vascular dementia.

    The HARMONY study was stopped early due to positive efficacy at the pre-planned interim analysis upon recommendation of the trial's independent data safety monitoring board. HARMONY met its primary endpoint by significantly reducing the risk of relapse of psychosis by 2.8 fold compared to placebo in the double-blind period (hazard ratio (HR)=0.35, two-sided p=0.005; one-sided p=0.0023). The study also met its secondary endpoint by significantly reducing the time to trial discontinuation for any reason (HR=0.45, two-sided p=0.005; one-sided p=0.0024). The data from the HARMONY study demonstrates that patients with DRP who had responded to pimavanserin had a significantly lower risk of relapse of psychosis with continuation of pimavanserin compared to placebo up to 26 weeks.

    "The relapse prevention design of the HARMONY study mirrors exactly what we do in clinical practice. This landmark trial showed that when patients responded to pimavanserin and then continued treatment, they were almost three times less likely to develop recurrence of their hallucinations and delusions than those patients who discontinued pimavanserin treatment," said the study's lead author, Dr. Pierre N. Tariot, Banner Alzheimer's Institute director. "This is a substantial finding and a significant advance for a critical public health need in our field. There is no FDA approved treatment for DRP, and the majority of antipsychotics currently used off-label have equivocal efficacy and may accelerate cognitive decline."

    Pimavanserin was well-tolerated over the nine-month study duration. In a pre-specified analysis, pimavanserin was not associated with a decline in cognition as measured by Mini-Mental State Examination (MMSE) or the onset or worsening of motor symptoms as measured by Extrapyramidal Symptom Rating Scale A (ESRS-A).

    "The HARMONY study findings demonstrated three important results. First, in the 12-week open-label period, pimavanserin treatment showed a sustained reduction of psychotic symptoms. Second, in the 26-week double-blind period, patients on pimavanserin had a nearly three-fold reduction of risk of psychosis relapse compared to patients on placebo. Third, pimavanserin was well-tolerated by elderly patients with DRP," said Steve Davis, Chief Executive Officer of Acadia. "We are very pleased that the New England Journal of Medicine has chosen to publish the important results of this study."

    About HARMONY

    HARMONY was a Phase 3 study designed to evaluate the efficacy and safety of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis. The study included patients with Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease dementia, and vascular dementia. A total of 392 patients were enrolled in the study, with a mean age of 74.5 years and a mean MMSE score of 16.7. The primary endpoint in the study was time from randomization to relapse of psychosis in the double-blind period as represented by the Kaplan-Meier curve and the hazard ratio.

    The HARMONY study included a 12-week, open-label stabilization period during which patients with dementia-related psychosis began treatment with pimavanserin 34 mg once daily. In the open-label period, a majority (61.8%) of eligible subjects (n=351) met the sustained treatment response criteria at Week 8 and Week 12 and entered the double-blind period. Following the open-label period, patients who met pre-specified criteria for sustained treatment response were then randomized into the double-blind period of the study to continue their pimavanserin dose or switched to placebo and followed for up to 26 weeks or until a relapse of psychosis occurred. Pimavanserin met its primary endpoint and was stopped at the pre-planned interim analysis for positive efficacy, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (HR=0.35, p=0.005).

    In the double-blind period, similar, low rates of adverse events were observed, 43 (41.0%) patients on pimavanserin (n=105) and 41 (36.6%) patients on placebo (n=112). Discontinuations in the double-blind period due to adverse events were low, 2.9% for pimavanserin and 3.6% for placebo. Rates of serious adverse events were also low, 4.8% in the pimavanserin group and 3.6% in the placebo group. One death was reported in the open-label period and one death was reported in the pimavanserin group during the double-blind period. Investigators determined that neither death was related to the study drug.

    About Dementia-Related Psychosis

    Approximately 8 million people in the United States are living with dementia, a condition with a core feature of declining cognition (changes in memory, decision-making abilities, language, etc.) resulting in functional impairment. Dementia is a manifestation of an underlying condition which is often progressive and neurodegenerative in nature.1 In addition to cognitive decline, dementing illnesses almost universally lead to neuropsychiatric symptoms, which may include hallucinations, delusions, and changes in behavior.

    It is estimated that 2.4 million Americans (or 30% of people with dementia) experience dementia-related hallucinations and delusions.2,3 These symptoms may be frequent and severe and may recur over time. A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed) in nature. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. Dementia-related psychosis occurs in many types of dementia, including Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia. Serious consequences have been associated with psychosis in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, faster progression of dementia, and increased risk of morbidity and mortality.4

    About Pimavanserin

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn and Twitter.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID® (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • Warnings and Precautions: QT Interval Prolongation
      • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

    References

    1Dementia. (2019, September 19). Retrieved from https://www.who.int/news-room/fact-sheets/detail/dementia.

    2Plassman BL, et al. Prevalence of dementia in the United States: The Aging Demographics, and Memory study. Neuroepidemiology. 2007;29(1-2):125-132.

    32017 Alzheimer's Disease Facts and Figures and Acadia market research.

    4Connors MH et al. Am J Geriatr Psychiatry 2018;26(3). Peters ME et al. Am J Psychiatry 2015;172(5). Haupt M et al. Int J Geriatr Psychiatry 1996;11(11). Naimark D et al. J Am Geriatr Soc 1996;44(3). Stern Y et al. Neurology 1994;44(12).

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  6. Company to host conference call and webcast on Wednesday, August 4, 2021, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report second quarter 2021 financial results on Wednesday, August 4, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on August 4, 2021, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 8065926). A telephone replay of the conference call may be accessed through August 18, 2021 by dialing 855-859-2056 for callers…

    Company to host conference call and webcast on Wednesday, August 4, 2021, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report second quarter 2021 financial results on Wednesday, August 4, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on August 4, 2021, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 8065926). A telephone replay of the conference call may be accessed through August 18, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 8065926). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there until September 1, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn and Twitter.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  7. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimer's Association International Conference® 2021 (AAIC®), being held July 26-30, 2021 in Denver, Colo., and virtually.

    The poster presentations include two analyses of patients who have neurodegenerative disease taking pimavanserin while also receiving other antidementia medication. One presentation focuses on safety outcomes while the second describes the impact of an acetylcholinesterase inhibitor (AChEI) on the pharmacokinetic profile of pimavanserin in patients with dementia-related psychosis. The third presentation will discuss a novel screening tool for psychosis in dementia patients…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimer's Association International Conference® 2021 (AAIC®), being held July 26-30, 2021 in Denver, Colo., and virtually.

    The poster presentations include two analyses of patients who have neurodegenerative disease taking pimavanserin while also receiving other antidementia medication. One presentation focuses on safety outcomes while the second describes the impact of an acetylcholinesterase inhibitor (AChEI) on the pharmacokinetic profile of pimavanserin in patients with dementia-related psychosis. The third presentation will discuss a novel screening tool for psychosis in dementia patients.

    AAIC Accepted Presentations:

    • Poster Presentation (#57661): Pimavanserin and concomitant antidementia medication use in patients with neurodegenerative and/or neurovascular disorders: safety outcomes from pooled clinical data and the HARMONY study, available to view starting Monday, July 26.

      Presenting Author: George Demos, M.D., Acadia Pharmaceuticals Inc.
    • Poster Presentation (#57479): Impact of concomitant acetylcholinesterase inhibitor use on the pharmacokinetic profile of pimavanserin in patients with dementia-related psychosis: modeling data from the Phase 3 HARMONY study, available to view starting Monday, July 26.

      Presenting Author: Mona Darwish, Ph.D., Acadia Pharmaceuticals Inc.
    • Poster Presentation (#57766): Development and Assessment of a Brief Screening Tool for Psychosis in Dementia, available to view starting Monday, July 26

      Presenting Author: Jeffrey Cummings, M.D., Sc.D., Joy Chambers-Grundy Professor of Brain Science, Vice Chair for Research, and Director of the Chambers-Gundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada Las Vegas (UNLV).

    About Pimavanserin

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn and Twitter.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID® (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • Warnings and Precautions: QT Interval Prolongation
      • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

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  8. - Patients previously treated with 34 mg showed sustained response

    - Patients on investigational doses and placebo demonstrated symptom improvement when switched to 34 mg dose during OLE

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced publication of open-label extension (OLE) data from patients experiencing hallucinations and delusions associated with Parkinson's disease psychosis (PDP) who had previously completed one of three, six-week, double-blind, placebo-controlled studies.

    The OLE efficacy analysis showed that patients previously on NUPLAZID 34 mg had a sustained efficacy response from Week 6 through Week 10, and that patients who had been treated with investigational doses of 8.5 mg and 17 mg or placebo also showed an improvement…

    - Patients previously treated with 34 mg showed sustained response

    - Patients on investigational doses and placebo demonstrated symptom improvement when switched to 34 mg dose during OLE

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced publication of open-label extension (OLE) data from patients experiencing hallucinations and delusions associated with Parkinson's disease psychosis (PDP) who had previously completed one of three, six-week, double-blind, placebo-controlled studies.

    The OLE efficacy analysis showed that patients previously on NUPLAZID 34 mg had a sustained efficacy response from Week 6 through Week 10, and that patients who had been treated with investigational doses of 8.5 mg and 17 mg or placebo also showed an improvement in the symptoms of psychosis when switched to NUPLAZID 34 mg over the 4 weeks of the OLE. The completed study was published online and in the June issue of Parkinsonism and Related Disorders. Full text of the paper can be found at: https://www.prdjournal.com/article/S1353-8020(21)00145-0/fulltext.

    "Results from a multi-center OLE study, across 14 countries, demonstrate the extended durability of efficacy of NUPLAZID for treating hallucinations and delusions associated with PDP, in addition to reinforcing the efficacy seen in the original pivotal trial using the 34 mg dose," said Stuart Isaacson, M.D., Director, Parkinson's Disease and Movement Disorders Center of Boca Raton. "As a physician, having NUPLAZID, an FDA-approved and proven therapy to treat these debilitating symptoms without impairing motor function, represents a major step forward. NUPLAZID is a critical first-line therapy for our patients living with PDP, and their caregivers."

    Importantly, non-motor symptoms of Parkinson's disease, including hallucinations and delusions, can be more troublesome than motor symptoms.1 Hallucinations and delusions can also worsen over time, making it difficult for patients to know whether or not what they are experiencing is real.2,3

    "We're pleased to have additional published data supporting the efficacy of NUPLAZID, as approximately 50 percent of people living with Parkinson's may experience hallucinations and delusions during the course of their disease," said Ponni Subbiah, M.D., M.P.H., Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer at Acadia. "These symptoms can have a significant impact on both patients and their families, negatively impacting their quality of life and causing severe emotional distress."

    About the Open-Label Extension (OLE) Study

    The OLE study was designed to evaluate the long-term safety of NUPLAZID. The publication includes an analysis of the efficacy results from the initial four weeks of the OLE study and included patients who had previously completed one of three, six-week, double-blind, placebo-controlled studies. All patients in the OLE were treated with NUPLAZID 34 mg. Changes in PDP symptoms were evaluated according to the Scale for the Assessment of Positive Symptoms (SAPS): the SAPS-PD and the Hallucinations + Delusions domains, Clinical Global Impression (CGI) Improvement and Severity scales and Caregiver Burden Scale (CBS).

    Of 459 patients enrolled in the OLE, 424 (92.4%) had a Week 4 efficacy assessment. Overall, the response to NUPLAZID 34 mg that was observed in the SAPS-PD scores during the initial six weeks persisted through Week 4 of the OLE (mean change from OLE baseline (standard deviation) to OLE Week 4 for the SAPS-PD of -0.8 (5.6)), while scores among patients switched from placebo to NUPLAZID 34 mg improved (with a mean change from OLE baseline to OLE Week 4 in the SAPS-PD of -2.9 (5.6)). For patients treated with pimavanserin 8.5 mg or 17 mg investigational doses in the previous studies, further improvement was observed during the OLE with NUPLAZID 34 mg.

    During the initial four weeks of the OLE study, adverse events (AEs) were reported by 215 (46.8%) patients. Twenty-seven (5.9%) patients had an AE that resulted in discontinuation of the study or study drug. The majority of AEs were of mild or moderate intensity; seven (1.5%) patients had serious AEs. The most common AEs were fall (5.9%), hallucination (3.7%), urinary tract infection (2.8%), insomnia (2.4%), and peripheral edema (2.2%). Complete safety findings from the OLE study over 9 years of study follow-up were previously published by Ballard CG, et al.4

    About Parkinson's Disease and Parkinson's Disease Psychosis

    Parkinson's disease is a progressive nervous system disorder that affects about one million people in the United States.5,6 The signs and symptoms can vary with people experiencing both motor symptoms and non-motor symptoms such as hallucinations (seeing, hearing, or experiencing things that others don't) and delusions (false beliefs).3,7 Physicians may refer to these Parkinson's-related hallucinations and delusions as Parkinson's disease psychosis (PDP).3 Around 50 percent of people living with Parkinson's may experience hallucinations or delusions during the course of their disease.7 Non-motor symptoms, as a whole, can be more troublesome than motor symptoms, in terms of quality of life.1 PDP may add to the burden of caring for a loved one with Parkinson's disease.8,9

    About NUPLAZID® (pimavanserin)

    NUPLAZID is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID® (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • Warnings and Precautions: QT Interval Prolongation
      • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

    1 Martinez-Martin P, Rodriguez-Blazquez C, et al. The Impact of Non-Motor Symptoms on Health Related Quality of Life of Patients with Parkinson's Disease. Mov Disord. 2011;26(3):399-406.

    2 Goetz, CG, Fan, W, Leurgans, S, et al. The malignant course of "benign hallucinations" in Parkinson disease. Archives of neurology. 2006;63(5), 713–716

    3 Ravina B, Marder K, Fernandez HH, et al. Diagnostic criteria for psychosis in Parkinson's disease: report of an NINDS, NIMH work group. Mov Disord. 2007 Jun 15;22(8):1061-8.

    4 Ballard CG, Kreitzman DL, Isaacson S, et al. Long-term evaluation of open-label pimavanserin safety and tolerability in Parkinson's disease psychosis. Parkinsonism Relat Disord. 2020;77:100-106.

    5 Parkinson's Disease Foundation. What is Parkinson's disease? Retrieved from https://www.pdf.org/en/about_pd. Accessed November 2014.

    6 Postuma, RB, et al. MDS Clinical Diagnostic Criteria for Parkinson's Disease. Mov Disorders. 2015; 30(12): 1591-1599

    7 Forsaa EB, Larsen JP, Wentzel-Larsen T, et al. A 12-year population-based study of psychosis in Parkinson's disease. Arch Neurol. 2010;67:996-1001.

    8 Schrag A, Hovris A, et al. Caregiver-burden in parkinson's disease is closely associated with psychiatric symptoms, falls, and disability. Parkonism and Related Disorders. 2006;12:35-41

    9 Aarsland D, Bronnick K, Ehrt U. et al. Neuropsychiatric symptoms in patients with Parkinson's disease and dementia: frequency, profile and associated care giver stress. J Neurol Neurosurg Psychiatry. 2007;78:36-42.

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  9. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    Jefferies 2021 Virtual Healthcare Conference
    Fireside Chat Presentation: Wednesday, June 2, 2021 at 1:30 p.m. Eastern Time

    Goldman Sachs 42nd Annual Global Healthcare Conference
    Fireside Chat Presentation: Tuesday, June 8, 2021 at 2:10 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    Jefferies 2021 Virtual Healthcare Conference

    Fireside Chat Presentation: Wednesday, June 2, 2021 at 1:30 p.m. Eastern Time

    Goldman Sachs 42nd Annual Global Healthcare Conference

    Fireside Chat Presentation: Tuesday, June 8, 2021 at 2:10 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    View Full Article Hide Full Article
  10. - 1Q21 net sales of $106.6 million, an 18% increase over 1Q20

    - Reiterating FY21 net sales guidance of $510 to $550 million

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), today announced its financial results for the first quarter ended March 31, 2021.

    "NUPLAZID delivered strong year-over-year performance in the first quarter of 2021. Looking ahead, we see positive signs in the Parkinson's disease psychosis market supporting revenue growth for the remainder of the year as we anticipate continued improvements in the conditions related to the pandemic," said Steve Davis, Chief Executive Officer. "Furthermore, we look forward to a Type A meeting with the FDA to discuss an approval path for pimavanserin in dementia-related psychosis and we continue…

    - 1Q21 net sales of $106.6 million, an 18% increase over 1Q20

    - Reiterating FY21 net sales guidance of $510 to $550 million

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), today announced its financial results for the first quarter ended March 31, 2021.

    "NUPLAZID delivered strong year-over-year performance in the first quarter of 2021. Looking ahead, we see positive signs in the Parkinson's disease psychosis market supporting revenue growth for the remainder of the year as we anticipate continued improvements in the conditions related to the pandemic," said Steve Davis, Chief Executive Officer. "Furthermore, we look forward to a Type A meeting with the FDA to discuss an approval path for pimavanserin in dementia-related psychosis and we continue to advance our two Phase 3 programs for Rett syndrome and the negative symptoms of schizophrenia, as well as our Phase 2 pain program and earlier pipeline opportunities."

    Company Updates

    • The Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The Company plans to conduct a Type A meeting with the FDA to discuss the CRL and potential next steps to support an approval.
    • Top-line results from the Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome are expected in the fourth quarter of 2021.
    • A Phase 2 study was initiated evaluating ACP-044, a novel, first-in-class, orally administered, non-opioid analgesic for the treatment of postoperative pain following bunionectomy surgery in March 2021.
    • A Phase 2 study evaluating ACP-044 for the treatment of pain associated with osteoarthritis is expected to commence in the second quarter of 2021.

    Financial Results

    Revenue

    Net sales of NUPLAZID (pimavanserin) were $106.6 million for the three months ended March 31, 2021, an increase of 18% as compared to $90.1 million reported for the three months ended March 31, 2020.

    Research and Development

    Research and development expenses for the three months ended March 31, 2021 were $57.0 million, compared to $72.6 million for the same period of 2020. This decrease was primarily due to the $10.0 million upfront payment to Vanderbilt University for the M1 PAM program incurred during the three months ended March 31, 2020 and decreased development costs associated with pimavanserin for major depressive disorder.

    Selling, General and Administrative

    Selling, general and administrative expenses for the three months ended March 31, 2021 were $111.7 million, compared to $102.0 million for the same period of 2020. This increase was primarily due to increased costs associated with preparations for the potential DRP launch, partially offset by a decrease in stock-based compensation expense.

    Net Loss

    For the three months ended March 31, 2021, Acadia reported a net loss of $66.4 million, or $0.42 per common share, compared to a net loss of $88.0 million, or $0.57 per common share, for the same period in 2020. The net losses for the three months ended March 31, 2021 and 2020 included $13.2 million and $22.3 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At March 31, 2021, Acadia's cash, cash equivalents, and investment securities totaled $577.8 million, compared to $632.0 million at December 31, 2020.

    2021 Financial Guidance

    • Acadia is reiterating its NUPLAZID net sales guidance of $510 to $550 million.
    • GAAP R&D guidance is decreased to $280 to $300 million from the previous range of $300 to $320 million. Current R&D guidance includes approximately $25 million of stock-based compensation expense.
    • GAAP SG&A guidance is decreased to $385 to $415 million from the previous range of $560 to $590 million. Previous guidance included additional investments associated with the potential DRP launch in 2021 and updated guidance reflects a reduction in these expenses. Current SG&A guidance includes approximately $50 million of stock-based compensation expense.

    Conference Call and Webcast Information

    Acadia management will review its first quarter financial results and operations via conference call and webcast today at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 4568937). A telephone replay of the conference call may be accessed through May 19, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 4568937). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com, under the investors section and will be archived there until June 2, 2021.

    About NUPLAZID® (pimavanserin)

    NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not approved for any other neuropsychiatric disorders. Acadia discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2021 NUPLAZID net sales for Parkinson's disease psychosis only and certain expense line items. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2021, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

     

     

    Three Months Ended March 31,

     

     

     

    2021

     

     

    2020

     

    Revenues

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    106,554

     

     

    $

    90,068

     

    Total revenues

     

     

    106,554

     

     

     

    90,068

     

    Operating expenses

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties (1)

     

     

    4,692

     

     

     

    4,974

     

    Research and development (1)

     

     

    56,973

     

     

     

    72,636

     

    Selling, general and administrative (1)

     

     

    111,661

     

     

     

    101,973

     

    Total operating expenses

     

     

    173,326

     

     

     

    179,583

     

    Loss from operations

     

     

    (66,772

    )

     

     

    (89,515

    )

    Interest income, net

     

     

    200

     

     

     

    2,989

     

    Other income (expense)

     

     

    145

     

     

     

    (1,497

    )

    Loss before income taxes

     

     

    (66,427

    )

     

     

    (88,023

    )

    Income tax expense

     

     

    21

     

     

     

     

    Net loss

     

    $

    (66,448

    )

     

    $

    (88,023

    )

    Net loss per common share, basic and diluted

     

    $

    (0.42

    )

     

    $

    (0.57

    )

    Weighted average common shares outstanding, basic and diluted

     

     

    160,011

     

     

     

    155,368

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    (1) Includes the following stock-based compensation expense

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties

     

    $

    163

     

     

    $

    849

     

    Research and development

     

    $

    4,830

     

     

    $

    8,457

     

    Selling, general and administrative

     

    $

    8,191

     

     

    $

    13,042

     

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

    March 31,

    2021

     

     

    December 31,

    2020

     

     

     

    (unaudited)

     

     

     

     

     

    Assets

     

     

     

     

     

     

     

     

    Cash, cash equivalents and investment securities

     

    $

    577,768

     

     

    $

    631,958

     

    Accounts receivable, net

     

     

    56,832

     

     

     

    48,247

     

    Interest and other receivables

     

     

    558

     

     

     

    2,035

     

    Inventory

     

     

    10,311

     

     

     

    9,682

     

    Prepaid expenses

     

     

    28,515

     

     

     

    25,694

     

    Total current assets

     

     

    673,984

     

     

     

    717,616

     

    Property and equipment, net

     

     

    9,757

     

     

     

    9,161

     

    Operating lease right-of-use assets

     

     

    63,111

     

     

     

    47,283

     

    Intangible assets, net

     

     

    738

     

     

     

    1,108

     

    Restricted cash

     

     

    5,770

     

     

     

    5,770

     

    Other assets

     

     

    1,813

     

     

     

    1,678

     

    Total assets

     

    $

    755,173

     

     

    $

    782,616

     

    Liabilities and stockholders' equity

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    8,849

     

     

    $

    8,493

     

    Accrued liabilities

     

     

    100,524

     

     

     

    97,474

     

    Total current liabilities

     

     

    109,373

     

     

     

    105,967

     

    Operating lease liabilities

     

     

    60,581

     

     

     

    44,460

     

    Other long-term liabilities

     

     

    3,613

     

     

     

    5,180

     

    Total liabilities

     

     

    173,567

     

     

     

    155,607

     

    Total stockholders' equity

     

     

    581,606

     

     

     

    627,009

     

    Total liabilities and stockholders' equity

     

    $

    755,173

     

     

    $

    782,616

     

     

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  11. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    BofA Securities 2021 Health Care Conference
    Fireside Chat Presentation: Wednesday, May 12, 2021 at 2:45 p.m. Eastern Time

    RBC Capital Markets Global Healthcare Conference
    Fireside Chat Presentation: Tuesday, May 18, 2021 at 3:05 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    BofA Securities 2021 Health Care Conference

    Fireside Chat Presentation: Wednesday, May 12, 2021 at 2:45 p.m. Eastern Time

    RBC Capital Markets Global Healthcare Conference

    Fireside Chat Presentation: Tuesday, May 18, 2021 at 3:05 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  12. Company to host conference call and webcast on Wednesday, May 5, 2021, at 5:00 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report first quarter 2021 financial results on Wednesday, May 5, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on May 5, 2021, at 5:00 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 4568937). A telephone replay of the conference call may be accessed through May 19, 2021 by dialing 855-859-2056 for callers in the United…

    Company to host conference call and webcast on Wednesday, May 5, 2021, at 5:00 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report first quarter 2021 financial results on Wednesday, May 5, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on May 5, 2021, at 5:00 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 4568937). A telephone replay of the conference call may be accessed through May 19, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 4568937). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there until June 2, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  13. - Conference call and webcast to be held today at 8:00 a.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA issued a CRL to indicate that they have completed their review of the application and has determined that the application cannot be approved in its present form.

    Despite prior agreements with the Division of Psychiatry regarding the pivotal Phase 3 HARMONY study design targeting a broad DRP patient population analyzed…

    - Conference call and webcast to be held today at 8:00 a.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA issued a CRL to indicate that they have completed their review of the application and has determined that the application cannot be approved in its present form.

    Despite prior agreements with the Division of Psychiatry regarding the pivotal Phase 3 HARMONY study design targeting a broad DRP patient population analyzed as a single group, the Division, in the CRL, cited a lack of statistical significance in some of the subgroups of dementia, and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval.

    The DRP pivotal HARMONY study met its prespecified primary and secondary endpoints with robust and persuasive clinical and statistical superiority of pimavanserin over placebo, which was a prospectively agreed prerequisite for the DRP indication. Statistical separation by dementia subgroups and certain minimum numbers of patients with specific subtypes were not among the prespecified requirements.

    "Acadia stands behind the robustly positive results from the pivotal Phase 3 HARMONY study and the prospectively agreed trial design and criteria for establishing efficacy in DRP. Over the entire course of the review, the Division did not raise any concerns regarding the agreed upon study design, including the issues raised in the CRL," said Steve Davis, Chief Executive Officer of Acadia. "We will immediately request a Type A meeting to work with the FDA to address the CRL and determine an expeditious path forward for the approval of pimavanserin in DRP."

    The Division also stated in the CRL that it considers the Phase 2 Alzheimer's disease psychosis study -019, a supportive study in the sNDA filing, to not be adequate and well controlled, citing that it was a single center study with no type I error control of secondary endpoints in which certain protocol deviations occurred. The Company believes these observations impact neither the positive results on the study's primary endpoint, nor the study's overall conclusions of efficacy.

    There were no safety issues or concerns raised in the CRL.

    sNDA Submission for Dementia-Related Psychosis

    The sNDA submission of pimavanserin for the treatment of hallucinations and delusions associated with DRP was supported by results from the pivotal Phase 3 HARMONY study, which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided p=0.0023). Pimavanserin also met the key secondary endpoint in the study, significantly reducing the risk of discontinuation for any reason by 2.2 fold compared to placebo (hazard ratio = 0.452, one-sided p=0.0024). The sNDA also included positive efficacy results from two additional placebo-controlled studies, both of which met their respective primary endpoints: the Phase 2 (-019) study in patients with Alzheimer's disease psychosis and the Phase 3 (-020) study in patients with Parkinson's disease psychosis. In addition, the sNDA included a large safety database from completed and ongoing studies representing over 1,500 patients with neurodegenerative disease.

    Conference Call and Webcast Information

    Acadia management will discuss today's announcement via conference call and webcast at 8:00 a.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 6894834). A telephone replay of the conference call may be accessed through April 19, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 6894834). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there through May 3, 2021.

    About Dementia-Related Psychosis

    Approximately 8 million people in the United States are living with dementia, a condition with a core feature of declining cognition (changes in memory, decision-making abilities, language, etc.) resulting in functional impairment. Dementia is a manifestation of an underlying condition which is often progressive and neurodegenerative in nature. In addition to cognitive decline, dementing illnesses almost universally lead to neuropsychiatric symptoms, including hallucinations, delusions, and changes in behavior.

    It is estimated that 2.4 million Americans (or 30% of people with dementia) experience dementia-related hallucinations and delusions. These symptoms may be frequent and severe and may recur over time. A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed) in nature. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. Dementia-related psychosis occurs in many types of dementia, including Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia. Serious consequences have been associated with psychosis in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, faster progression of dementia, and increased risk of morbidity and mortality.

    About Pimavanserin

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID® (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

    NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.

     

    Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.

     

    Warnings and Precautions: QT Interval Prolongation

    °

    NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.

    °

    NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.

     

    Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).

     

    Drug Interactions:

    °

    Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.

    °

    Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

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  14. - Conference call and webcast to be held today at 5:00 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company received a notification from the U.S. Food and Drug Administration (FDA) on March 3, 2021, stating that, as part of its ongoing review of the Company's supplemental New Drug Application (sNDA), the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.

    The notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time. The Company plans to work with the FDA…

    - Conference call and webcast to be held today at 5:00 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company received a notification from the U.S. Food and Drug Administration (FDA) on March 3, 2021, stating that, as part of its ongoing review of the Company's supplemental New Drug Application (sNDA), the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.

    The notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time. The Company plans to work with the FDA to learn the nature of the deficiencies and seek to resolve them. In July 2020, the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2021 for completion of its review of the sNDA.

    Conference Call and Webcast Information

    Acadia management will discuss today's announcement via conference call and webcast at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 4153316). A telephone replay of the conference call may be accessed through March 15, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 4153316). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there through April 8, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID® (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • Warnings and Precautions: QT Interval Prolongation
      • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

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  15. - Full year 2020 net sales grew to $441.8 million, a 30% increase over 2019

    - Upcoming PDUFA action date of April 3, 2021 for supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2020.

    "Acadia delivered strong financial results in the fourth quarter and full year 2020, driven by robust sales of NUPLAZID in Parkinson's disease psychosis. Additionally, we made significant advancements in two Phase 3 programs and further expanded our pipeline in pain and neuropsychiatry through strategic business development," said Steve…

    - Full year 2020 net sales grew to $441.8 million, a 30% increase over 2019

    - Upcoming PDUFA action date of April 3, 2021 for supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2020.

    "Acadia delivered strong financial results in the fourth quarter and full year 2020, driven by robust sales of NUPLAZID in Parkinson's disease psychosis. Additionally, we made significant advancements in two Phase 3 programs and further expanded our pipeline in pain and neuropsychiatry through strategic business development," said Steve Davis, Chief Executive Officer. "In 2021, we are focused on delivering continued growth of NUPLAZID, the upcoming potential approval and launch of pimavanserin for dementia-related psychosis and advancing our business development strategy."

    Company Highlights

    • Upcoming PDUFA (Prescription Drug User Fee Act) date of April 3, 2021 for supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis.
    • Top-line results from Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome expected in the fourth quarter of 2021.
    • Two Phase 2 clinical studies evaluating ACP-044, a novel, first-in-class, orally administered, non-opioid analgesic, in acute and chronic pain to commence in first half of 2021. A bunionectomy study is expected to initiate in the first quarter of 2021 and an osteoarthritis study is expected to initiate in the second quarter of 2021.
    • In November 2020, the FDA approved a label update to allow the NUPLAZID capsule to be sprinkled on certain foods. This is an important feature for patients who take oral medications and may have difficulty swallowing; a potential issue for Parkinson's disease patients and in the elderly in general.
    • Kathie Bishop, Ph.D., joined Acadia as Senior Vice President, Head of Rare Disease and Diann Potestio joined Acadia as Senior Vice President, Market Access, Reimbursement and Channel Strategy.

    Financial Results

    Revenue

    Net sales of NUPLAZID® (pimavanserin) were $121.0 million for the fourth quarter of 2020, an increase of 23% as compared to $98.3 million reported for the fourth quarter of 2019. For the years ended December 31, 2020 and 2019, Acadia reported net product sales of $441.8 million and $339.1 million, respectively, an increase of 30% year-over-year.

    Research and Development

    Research and development expenses for the fourth quarter of 2020 were $62.1 million, compared to $57.5 million for the same period of 2019. For the years ended December 31, 2020 and 2019, research and development expenses were $319.1 million and $240.4 million, respectively. The increase in full year 2020 was primarily due to the upfront expenses of $52.8 million related to the acquisition of CerSci Therapeutics and a $10.0 million upfront payment to Vanderbilt University related to the license agreement and collaboration for novel therapeutic programs targeting muscarinic M1 receptors.

    Selling, General and Administrative

    Selling, general and administrative expenses for the fourth quarter of 2020 were $120.8 million, compared to $91.9 million for the same period of 2019. For the years ended December 31, 2020 and 2019, selling, general and administrative expenses were $388.7 million and $325.6 million, respectively. This increase during the 2020 period as compared to 2019 was primarily due to increased advertising and promotional costs, dementia-related psychosis launch preparation expenses, as well as an increase in personnel and related costs.

    Net Loss

    For the fourth quarter of 2020, Acadia reported a net loss of $66.8 million, or $0.42 per common share, compared to a net loss of $53.0 million, or $0.34 per common share, for the same period in 2019. The net losses for the fourth quarters of 2020 and 2019 included $21.2 million and $19.8 million, respectively, of non-cash stock-based compensation expense. For the year ended December 31, 2020, Acadia reported a net loss of $281.6 million, or $1.79 per common share, compared to a net loss of $235.3 million, or $1.60 per common share, for the same period in 2019. The net losses for the years ended December 31, 2020 and 2019 included $84.4 million and $82.3 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At December 31, 2020, Acadia's cash, cash equivalents, and investment securities totaled $632.0 million, compared to $697.4 million at December 31, 2019.

    2021 Financial Guidance

    • Net sales guidance for NUPLAZID in Parkinson's disease psychosis (PDP) of $510 to $550 million. As this is the potential launch year for dementia-related psychosis (DRP), the Company is not including revenue projections for DRP in 2021 net sales guidance.
    • GAAP R&D guidance of $300 to $320 million reflects the progression of candidates in five clinical indications this year. This guidance includes approximately $30 million of share-based compensation expense.
    • GAAP SG&A guidance of $560 to $590 million reflects a similar level of investment to 2020 in PDP activities, together with additional investments associated with a potential DRP launch. This guidance includes approximately $60 million of share-based compensation expense.

    Conference Call and Webcast Information

    Acadia management will review its fourth quarter and full year 2020 financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9576845). A telephone replay of the conference call may be accessed through March 10, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9576845). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there through March 24, 2021.

    About NUPLAZID® (pimavanserin)

    NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not FDA-approved for dementia-related psychosis, schizophrenia, major depressive disorder, or depressive symptoms in patients with Parkinson's disease. Acadia discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino-terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2021 NUPLAZID net sales for Parkinson's disease psychosis only and certain expense line items. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2021, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2019 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

     

     

    Three Months Ended December 31,

     

     

    Years Ended December 31,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenues

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    121,007

     

     

    $

    98,326

     

     

    $

    441,755

     

     

    $

    339,076

     

    Total revenues

     

     

    121,007

     

     

     

    98,326

     

     

     

    441,755

     

     

     

    339,076

     

    Operating expenses

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties (1)

     

     

    5,301

     

     

     

    5,334

     

     

     

    20,550

     

     

     

    19,598

     

    Research and development (1)

     

     

    62,116

     

     

     

    57,520

     

     

     

    319,130

     

     

     

    240,385

     

    Selling, general and administrative (1)

     

     

    120,752

     

     

     

    91,871

     

     

     

    388,661

     

     

     

    325,638

     

    Total operating expenses

     

     

    188,169

     

     

     

    154,725

     

     

     

    728,341

     

     

     

    585,621

     

    Loss from operations

     

     

    (67,162

    )

     

     

    (56,399

    )

     

     

    (286,586

    )

     

     

    (246,545

    )

    Interest income, net

     

     

    554

     

     

     

    3,272

     

     

     

    6,610

     

     

     

    11,165

     

    Other income (expense)

     

     

    265

     

     

     

    491

     

     

     

    (997

    )

     

     

    997

     

    Loss before income taxes

     

     

    (66,343

    )

     

     

    (52,636

    )

     

     

    (280,973

    )

     

     

    (234,383

    )

    Income tax (benefit) expense

     

     

    417

     

     

     

    400

     

     

     

    611

     

     

     

    876

     

    Net loss

     

    $

    (66,760

    )

     

    $

    (53,036

    )

     

    $

    (281,584

    )

     

    $

    (235,259

    )

    Net loss per common share, basic and diluted

     

    $

    (0.42

    )

     

    $

    (0.34

    )

     

    $

    (1.79

    )

     

    $

    (1.60

    )

    Weighted average common shares outstanding, basic and diluted

     

     

    159,263

     

     

     

    154,492

     

     

     

    157,331

     

     

     

    147,199

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    (1) Includes the following share-based compensation expenses

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties

     

    $

    545

     

     

    $

    592

     

     

    $

    2,632

     

     

    $

    2,936

     

    Research and development

     

    $

    7,669

     

     

    $

    8,072

     

     

    $

    31,314

     

     

    $

    32,533

     

    Selling, general and administrative

    $

    12,981

     

    $

    11,099

     

    $

    50,476

     

    $

    46,796

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

     

    December 31,

    2020

     

     

    December 31,

    2019

     

     

     

    (unaudited)

     

     

     

     

     

    Assets

     

     

     

     

     

     

     

     

    Cash, cash equivalents and investment securities

     

    $

    631,958

     

     

    $

    697,429

     

    Accounts receivable, net

     

     

    48,247

     

     

     

    35,781

     

    Interest and other receivables

     

     

    2,035

     

     

     

    2,093

     

    Inventory

     

     

    9,682

     

     

     

    6,341

     

    Prepaid expenses

     

     

    25,694

     

     

     

    18,606

     

    Total current assets

     

     

    717,616

     

     

     

    760,250

     

    Property and equipment, net

     

     

    9,161

     

     

     

    3,180

     

    Operating lease right-of-use assets

     

     

    47,283

     

     

     

    9,524

     

    Intangible assets, net

     

     

    1,108

     

     

     

    2,585

     

    Restricted cash

     

     

    5,770

     

     

     

    4,787

     

    Other assets

     

     

    1,678

     

     

     

    2,857

     

    Total assets

     

    $

    782,616

     

     

    $

    783,183

     

    Liabilities and stockholders' equity

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    8,493

     

     

    $

    7,222

     

    Accrued liabilities

     

     

    97,474

     

     

     

    67,604

     

    Total current liabilities

     

     

    105,967

     

     

     

    74,826

     

    Operating lease liabilities

     

     

    44,460

     

     

     

    6,361

     

    Long-term liabilities

     

     

    5,180

     

     

     

    2,861

     

    Total liabilities

     

     

    155,607

     

     

     

    84,048

     

    Total stockholders' equity

     

     

    627,009

     

     

     

    699,135

     

    Total liabilities and stockholders' equity

     

    $

    782,616

     

     

    $

    783,183

     

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  16. -  Educational resources help caregivers of the estimated 2.4 million people living with dementia-related hallucinations and delusions identify and discuss symptoms

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the launch of MoreThanMemoryLoss.com, a new website with educational resources designed to help caregivers and people living with dementia to learn more about dementia-related hallucinations and delusions.

    "As a leading, national caregiver organization, we hear from dementia caregivers every day about the challenges they experience caring for loved ones with behavioral symptoms of dementia. This new resource provides information and support to address these symptoms that can have a devastating impact on families," said…

    -  Educational resources help caregivers of the estimated 2.4 million people living with dementia-related hallucinations and delusions identify and discuss symptoms

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the launch of MoreThanMemoryLoss.com, a new website with educational resources designed to help caregivers and people living with dementia to learn more about dementia-related hallucinations and delusions.

    "As a leading, national caregiver organization, we hear from dementia caregivers every day about the challenges they experience caring for loved ones with behavioral symptoms of dementia. This new resource provides information and support to address these symptoms that can have a devastating impact on families," said John Schall, Chief Executive Officer, Caregiver Action Network.

    MoreThanMemoryLoss.com was developed following extensive caregiver research and input from advocacy organizations. The site offers educational and actionable resources for visitors, including a doctor discussion guide, a dementia-related hallucinations and delusions fact sheet and an adapted personal story from a caregiver coping with a loved one's experience of these symptoms.

    Dementia affects 8 million people in the U.S. and its prevalence is expected to increase as the population ages.1-4 Approximately 30 percent, or 2.4 million people in the U.S., experience dementia-related psychosis and only half of them, or 1.2 million, are diagnosed.1,5 Symptoms of dementia-related psychosis include hallucinations, when someone experiences things that are not there, such as seeing or hearing things that others do not and delusions, when someone believes things that are not true, such as people are talking about you (paranoia), or fear that someone is stealing from you. These symptoms are also very distressing for family and caregivers and may be associated with increased risk of aggressive behavior in dementia patients.6 Hallucinations and delusions can cause a person to lose touch with reality, and their loved ones to lose touch with them.

    "Caregivers often believe their job is to protect the image of their loved one and to hide the symptoms of dementia-related psychosis from others," said Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer, at Acadia Pharmaceuticals. "MoreThanMemoryLoss.com is an educational resource dedicated to providing caregivers with information and tools needed to start important conversations about dementia-related hallucinations and delusions with their loved one's healthcare providers."

    Visit https://www.morethanmemoryloss.com to learn more, and sign up for additional educational resources.

    About Dementia-Related Psychosis

    Approximately 8 million people in the United States are living with dementia, a condition with a core feature of declining cognition (changes in memory, decision-making abilities, language, etc.) resulting in functional impairment. Dementia is a manifestation of an underlying condition which is often progressive and neurodegenerative in nature.7 In addition to cognitive decline, dementing illnesses almost universally lead to neuropsychiatric symptoms, including hallucinations, delusions, and changes in behavior.

    It is estimated that 2.4 million Americans (or 30% of people with dementia) experience dementia-related hallucinations and delusions. These symptoms may be frequent and severe and may recur over time. A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed) in nature. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. Dementia-related psychosis occurs in many types of dementia, including Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia. Serious consequences have been associated with psychosis in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, progression of dementia, and increased risk of morbidity and mortality.8

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    References

    1Plassman BL, Langa KM, Fisher GG, et al. Prevalence of dementia in the United States: the aging, demographics, and memory study. Neuroepidemiology. 2007;29(1-2):125-132.

    2Goodman RA, Lochner KA, Thambisetty M, et al. Prevalence of dementia subtypes in United States Medicare fee—for—service beneficiaries, 2011—2013. Alzheimers Dement. 2017;13(1):28—37.

    3Hebert LE, Weuve J, Scherr PA, et al. Alzheimer disease in the United States (2010-2050) estimated using the 2010 census. Neurology. 2013;80(19):1778-1783.

    4Alzheimer's Association. 2020 Alzheimer's disease facts and figures. Alzheimer's Dement. 2020;16(3):391-485

    52017 Alzheimer's Disease Facts and Figures and Acadia market research.

    6Lopez O, et al. Psychiatric symptoms vary with the severity of dementia in probable Alzheimer's disease. J Neuropsychiatry Clin Neurosci. 2003;153:346-353.

    7Dementia. (2019, September 19). Retrieved from https://www.who.int/news-room/fact-sheets/detail/dementia.

    8Connors MH et al. Am J Geriatr Psychiatry 2018;26(3). Peters ME et al. Am J Psychiatry 2015;172(5). Haupt M et al. Int J Geriatr Psychiatry 1996;11(11). Naimark D et al. J Am Geriatr Soc 1996;44(3). Stern Y et al. Neurology 1994;44(12).

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  17. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    10th Annual SVB Leerink Global Healthcare Conference
    Fireside Chat Presentation: Friday, February 26, 2021 at 10:40 a.m. Eastern Time

    Cowen 41st Annual Health Care Conference
    Fireside Chat Presentation: Monday, March 1, 2021 at 12:20 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About Acadia Pharmaceuticals
    Acadia is trailblazing breakthroughs in neuroscience to…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    10th Annual SVB Leerink Global Healthcare Conference

    Fireside Chat Presentation: Friday, February 26, 2021 at 10:40 a.m. Eastern Time

    Cowen 41st Annual Health Care Conference

    Fireside Chat Presentation: Monday, March 1, 2021 at 12:20 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  18. Company to host conference call and webcast on Wednesday, February 24, 2021, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report fourth quarter and full year 2020 financial results on Wednesday, February 24, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on February 24, 2021, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9576845). A telephone replay of the conference call may be accessed through March 10, 2021 by dialing…

    Company to host conference call and webcast on Wednesday, February 24, 2021, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report fourth quarter and full year 2020 financial results on Wednesday, February 24, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on February 24, 2021, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9576845). A telephone replay of the conference call may be accessed through March 10, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9576845). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there until March 24, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2019 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  19. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that Michael Yang, Executive Vice President and Chief Commercial Officer, will be leaving the organization effective January 29, 2021 to assume the role of chief executive officer at another healthcare company. Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer and Amanda Morgan, Senior Vice President, Chief Revenue and Customer Officer, will lead the commercial organization.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210127005903/en/

    Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer (Photo: Business Wire)

    Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer (Photo: Business Wire)

    "On behalf of the entire management…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that Michael Yang, Executive Vice President and Chief Commercial Officer, will be leaving the organization effective January 29, 2021 to assume the role of chief executive officer at another healthcare company. Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer and Amanda Morgan, Senior Vice President, Chief Revenue and Customer Officer, will lead the commercial organization.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210127005903/en/

    Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer (Photo: Business Wire)

    Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer (Photo: Business Wire)

    "On behalf of the entire management team and our employees, I want to thank Michael for his significant contributions and we wish him well in his future endeavors," said Steve Davis, Chief Executive Officer. "Amanda and Charmaine have been the foundation of our commercial success and I look forward to their continued leadership."

    Charmaine Lykins, Senior Vice President, Global Product Planning and Chief Marketing Officer

    Charmaine Lykins is Senior Vice President, Global Product Planning and Chief Marketing Officer and leads Acadia's healthcare professional and consumer marketing, marketing operations and new product planning functions. She joined the company in 2018 as Vice President, Marketing and in 2019 was promoted to Senior Vice President and became a member of the company's Executive Management Committee.

    Ms. Lykins has over 25 years of global experience commercializing healthcare brands, including 10 product launches representing first-in-class therapies for central nervous system disorders. She led the U.S. launch teams for REXULTI® in depression and schizophrenia, prelaunch readiness for ABILIFY MAINTENA® in bipolar disorder, and ZIPSOR® for acute pain. Ms. Lykins also led commercial launch strategies for LATUDA® in bipolar depression and schizophrenia, CYMBALTA® for depression and diabetic neuropathic pain, and ZYPREXA® for bipolar depression and treatment resistant depression in combination with fluoxetine.

    Prior to joining Acadia, Ms. Lykins served as Global Vice President of Marketing at Lundbeck. Prior to Lundbeck she held global marketing leadership roles at Sunovion and U.S. marketing and sales leadership roles at Eli Lilly. Her career experience includes strategic commercialization roles in Europe, Asia, and the Middle East, as well as in research and development.

    Ms. Lykins has an MBA with an emphasis in international business from the Darla Moore School of Business at University of South Carolina, and bachelor's degrees in chemistry and honors humanities from Ball State University.

    Amanda Morgan, Senior Vice President, Chief Revenue and Customer Officer

    Amanda Morgan is Senior Vice President, Chief Revenue and Customer Officer and leads Acadia's neuroscience, long-term care, national accounts, and health systems. She joined the company in 2017 as Vice President, Sales and Market Access and in 2019 was promoted to Senior Vice President and became a member of the company's Executive Management Committee.

    Ms. Morgan has over 20 years of experience in developing high-performing cultures and teams in the healthcare industry. Prior to joining Acadia, she was the U.S. Head of Patient Services at Baxalta where she was responsible for launching the patient services organization that supported more than $6 billion dollars in revenue. Prior to Baxalta, she was U.S. Area Vice President at Baxter leading the hospital and healthcare sales teams overseeing market expansion, supplemental indications, and new product launch strategies.

    Throughout her career, Ms. Morgan has held leadership roles with increasing responsibility in marketing, sales, market access, patient services and operations in multiple therapeutic areas. She has a strong track record of executing commercial strategies in neuroscience, immunology, hematology, and oncology, as well as in rare diseases.

    Ms. Morgan earned her Bachelor of Science degree in Business Administration, Marketing from The University of Iowa.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  20. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021, at 2:00 p.m. Eastern Time, followed by a question and answer session.

    The conference will be held virtually. A live audio-only webcast of Acadia's presentation and question and answer session, along with accompanying slides, will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through February 12, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021, at 2:00 p.m. Eastern Time, followed by a question and answer session.

    The conference will be held virtually. A live audio-only webcast of Acadia's presentation and question and answer session, along with accompanying slides, will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through February 12, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  21. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020, at 3:20 p.m. Eastern Time.

    The conference will be held virtually. A live webcast of Acadia's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through December 15, 2020.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020, at 3:20 p.m. Eastern Time.

    The conference will be held virtually. A live webcast of Acadia's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through December 15, 2020.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  22. - 3Q20 Net Sales of $120.6 Million, a 27% Increase Over 3Q19

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the third quarter ended September 30, 2020.

    "This quarter we drove strong performance through the continued growth of new prescribers with more patients benefitting from NUPLAZID® treatment for their Parkinson's disease psychosis and remain on-track with our supplemental NDA for the treatment of dementia-related psychosis with a PDUFA date of April 3, 2021," said Steve Davis, Acadia's Chief Executive Officer. "We continue to advance…

    - 3Q20 Net Sales of $120.6 Million, a 27% Increase Over 3Q19

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the third quarter ended September 30, 2020.

    "This quarter we drove strong performance through the continued growth of new prescribers with more patients benefitting from NUPLAZID® treatment for their Parkinson's disease psychosis and remain on-track with our supplemental NDA for the treatment of dementia-related psychosis with a PDUFA date of April 3, 2021," said Steve Davis, Acadia's Chief Executive Officer. "We continue to advance our late-stage programs and invest in new opportunities through business development, highlighted by our recent acquisition of CerSci Therapeutics which expands our clinical pipeline with an innovative first-in-class, non-opioid, acute and chronic pain program."

    Company Updates

    • New clinical analyses across multiple studies of pimavanserin are being presented at this week's 13th Clinical Trials on Alzheimer's Disease (CTAD) meeting, including:
      • Oral presentation by Dr. Clive Ballard, University of Exeter Medical School: "Impact of Pimavanserin on Cognitive Measures in Patients with Neurodegenerative Disease: Results from 4 Placebo-Controlled Clinical Studies."
      • Poster presentation by Dr. Daniel Weintraub, Perelman School of Medicine at the University of Pennsylvania: "Impact of Pimavanserin Treatment on Motor Function in Patients with Neurodegenerative Disease: Results from 3 Clinical Studies."
    • In October, Acadia announced a partnership with The Lewy Body Dementia Association (LBDA) on the release of a disease education adaptation of the new documentary Robin's Wish©. The film is titled, "SPARK - Robin Williams and his Battle with Lewy Body Dementia©," and will be available to academic research institutions and universities as part of educational programming for healthcare professionals.
    • In October, Acadia presented a poster titled "Healthcare Resource Utilization and Associated Costs for Dementia Patients with Psychosis: A Medicare Database Study," at the Academy of Managed Care Pharmacy's (AMCP) Nexus conference, and received a Silver ribbon based on its relevance, originality, quality, bias and clarity of results.
    • In August, Acadia acquired CerSci Therapeutics, a clinical-stage biotechnology company with worldwide rights to a portfolio of novel compounds for neurological conditions, including non-opioid therapies for acute and chronic pain. Acadia plans to initiate a Phase 2 program with the lead compound, ACP-044, in the first half of 2021.
    • Appointed Dr. Gudarz Davar as Executive Vice President and Head of Research and Development, reporting to Serge Stankovic, M.D., M.S.P.H., President of Acadia.
    • Elizabeth (Betsy) Garofalo, M.D. was appointed to the Acadia Board of Directors.

    Financial Results

    Revenue

    Net sales of NUPLAZID (pimavanserin) were $120.6 million for the three months ended September 30, 2020, an increase of 27% as compared to $94.6 million reported for the three months ended September 30, 2019. For the nine months ended September 30, 2020 and 2019, Acadia reported net product sales of $320.7 million and $240.8 million, respectively.

    Research and Development

    Research and development expenses for the three months ended September 30, 2020 were $120.1 million, compared to $62.6 million for the same period of 2019. This increase was primarily due to $52.8 million in upfront consideration and transaction expenses related to the acquisition of CerSci Therapeutics. For the nine months ended September 30, 2020 and 2019, research and development expenses were $257.0 million and $182.9 million, respectively. This increase was primarily due to the acquisition of CerSci Therapeutics and the upfront payment to Vanderbilt University for the M1 PAM program.

    Selling, General and Administrative

    Selling, general and administrative expenses for the three months ended September 30, 2020 were $81.6 million, compared to $72.7 million for the same period of 2019. For the nine months ended September 30, 2020 and 2019, selling, general and administrative expenses were $267.9 million and $233.8 million, respectively. This increase was primarily due to increased advertising and promotional costs as well as an increase in personnel and related costs.

    Net Loss

    For the three months ended September 30, 2020, Acadia reported a net loss of $84.7 million, or $0.54 per common share, compared to a net loss of $42.0 million, or $0.29 per common share, for the same period in 2019. The net losses for the three months ended September 30, 2020 and 2019 included $21.4 million and $22.0 million, respectively, of non-cash stock-based compensation expense. For the nine months ended September 30, 2020, Acadia reported a net loss of $214.8 million, or $1.37 per common share, compared to a net loss of $182.2 million, or $1.26 per common share, for the same period in 2019. The net losses for the nine months ended September 30, 2020 and 2019 included $63.2 million and $62.5 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At September 30, 2020, Acadia's cash, cash equivalents, and investment securities totaled $644.4 million, compared to $697.4 million at December 31, 2019.

    2020 Financial Guidance

    • Acadia reiterates its NUPLAZID net sales guidance of $430 to $450 million.
    • GAAP R&D guidance is increased to $325 to $340 million from the previous range of $265 to $280 million, primarily as a result of the $52.8 million upfront and transaction expenses associated with the acquisition of CerSci Therapeutics.
    • GAAP SG&A guidance is decreased to $385 to $400 million from the previous range of $400 to $420 million.
    • Non-cash stock-based compensation expense guidance is decreased to $80 to $90 million from the previous range of $90 to $100 million.
    • 2020 year-end cash, cash equivalents, and investment securities guidance of $570 to $590 million is unchanged.

    Conference Call and Webcast Information

    Acadia management will review its third quarter financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 6266016). A telephone replay of the conference call may be accessed through November 18, 2020 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 6266016). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com, under the investors section and will be archived there until December 2, 2020.

    About NUPLAZID® (pimavanserin)

    NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not FDA-approved for any other neuropsychiatric disorders. Acadia discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino-terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide, ACP-044 and the M1 PAM program; unanticipated impacts of COVID-19 on Acadia's business, including its commercial sales operations, current and planned clinical trials, supply chain, and guidance for full-year 2020 NUPLAZID net sales and certain expense line items. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2020, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2019 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Copyright 2020 by Tiburon Sunrise, LLC

     

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

     

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenues

     

     

     

     

     

     

     

     

     

     

     

     

    Product sales, net

    $

    120,577

     

    $

    94,586

     

    $

    320,748

     

    $

    240,750

     

    Total revenues

     

    120,577

     

     

    94,586

     

     

    320,748

     

     

    240,750

     

    Operating expenses

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties (1)

     

    4,801

     

     

    4,689

     

     

    15,249

     

     

    14,264

     

    Research and development (1)

     

    120,083

     

     

    62,622

     

     

    257,014

     

     

    182,865

     

    Selling, general and administrative (1)

     

    81,592

     

     

    72,696

     

     

    267,909

     

     

    233,767

     

    Total operating expenses

     

    206,476

     

     

    140,007

     

     

    540,172

     

     

    430,896

     

    Loss from operations

     

    (85,899

    )

     

    (45,421

    )

     

    (219,424

    )

     

    (190,146

    )

    Interest income, net

     

    1,242

     

     

    2,432

     

     

    6,056

     

     

    7,893

     

    Other (expense) income

     

    (202

    )

     

    747

     

     

    (1,262

    )

     

    506

     

    Loss before income taxes

     

    (84,859

    )

     

    (42,242

    )

     

    (214,630

    )

     

    (181,747

    )

    Income tax expense

     

    (199

    )

     

    (264

    )

     

    194

     

     

    476

     

    Net loss

    $

    (84,660

    )

    $

    (41,978

    )

    $

    (214,824

    )

    $

    (182,223

    )

    Net loss per common share, basic and diluted

    $

    (0.54

    )

    $

    (0.29

    )

    $

    (1.37

    )

    $

    (1.26

    )

    Weighted average common shares outstanding, basic and diluted

     

    158,129

     

     

    145,906

     

     

    156,683

     

     

    144,741

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    (1) Includes the following stock-based compensation expense

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties

    $

    495

     

    $

    372

     

    $

    2,087

     

    $

    2,344

     

    Research and development

    $

    7,953

     

    $

    8,680

     

    $

    23,645

     

    $

    24,461

     

    Selling, general and administrative

    $

    12,924

     

    $

    12,971

     

    $

    37,495

     

    $

    35,697

     

     

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

     

    September 30,

    2020

     

    December 31,

    2019

     

     

    (unaudited)

     

     

     

    Assets

     

     

     

     

    Cash, cash equivalents and investment securities

    $

    644,441

    $

    697,429

    Accounts receivable, net

     

    46,344

     

    35,781

    Interest and other receivables

     

    1,440

     

    2,093

    Inventory

     

    7,979

     

    6,341

    Prepaid expenses

     

    30,009

     

    18,606

    Total current assets

     

    730,213

     

    760,250

    Property and equipment, net

     

    8,427

     

    3,180

    Operating lease right-of-use assets

     

    48,232

     

    9,524

    Intangible assets, net

     

    1,477

     

    2,585

    Restricted cash

     

    5,770

     

    4,787

    Other assets

     

    1,545

     

    2,857

    Total assets

    $

    795,664

    $

    783,183

    Liabilities and stockholders' equity

     

     

     

     

    Accounts payable

    $

    3,471

    $

    7,222

    Accrued liabilities

     

    88,385

     

    67,604

    Total current liabilities

     

    91,856

     

    74,826

    Operating lease liabilities

     

    45,343

     

    6,361

    Other long-term liabilities

     

    3,598

     

    2,861

    Total liabilities

     

    140,797

     

    84,048

    Total stockholders' equity

     

    654,867

     

    699,135

    Total liabilities and stockholders' equity

    $

    795,664

    $

    783,183

     

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  23. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that scientific presentations highlighting new analyses of pimavanserin clinical study data in dementia-related psychosis and neurodegenerative diseases will be shared at the 13th Clinical Trials on Alzheimer's Disease Conference (CTAD), being held virtually November 4-7, 2020.

    Scientific presentations include those investigating pimavanserin treatment and its impact on cognition and motor function in patients with neuropsychiatric symptoms related to neurodegenerative diseases, including dementia-related psychosis. Other presentations include a comprehensive literature review of current use of antipsychotic treatment for dementia-related psychosis, an analysis of mortality risk and…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that scientific presentations highlighting new analyses of pimavanserin clinical study data in dementia-related psychosis and neurodegenerative diseases will be shared at the 13th Clinical Trials on Alzheimer's Disease Conference (CTAD), being held virtually November 4-7, 2020.

    Scientific presentations include those investigating pimavanserin treatment and its impact on cognition and motor function in patients with neuropsychiatric symptoms related to neurodegenerative diseases, including dementia-related psychosis. Other presentations include a comprehensive literature review of current use of antipsychotic treatment for dementia-related psychosis, an analysis of mortality risk and need for long-term care for patients with dementia-related psychosis versus patients with dementia only, and assessments of efficacy and safety of pimavanserin in dementia-related psychosis.

    CTAD Accepted Scientific Presentations include:

    Oral Presentations:

    • Oral Presentation (OC31): Impact of Pimavanserin on Cognitive Measures in Patients with Neurodegenerative Disease: Results from 4 Placebo-Controlled Clinical Studies on Friday, November 6, 10:45 – 11:00 a.m. ET. Presenting author: Clive Ballard, MBChB, University of Exeter Medical School, Exeter, United Kingdom.
    • Oral Presentation (OC17): Relationship Between Pimavanserin Exposure and Psychosis Relapse in Patients with Dementia-Related Psychosis: Clinical Results and Modeling Analysis from the Phase 3 HARMONY Study on Thursday, November 5, 10:30 – 10:45 a.m. ET. Presenting author: Mona Darwish, Acadia Pharmaceuticals Inc.

    Poster Presentations:

    • Poster Presentation (P75): Impact of Pimavanserin Treatment on Motor Function in Patients with Neurodegenerative Disease: Results from 3 Clinical Studies. Presenting author: Daniel Weintraub, M.D., Departments of Psychiatry and Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
    • Poster Presentation (P21): Frequency of Antipsychotic-Associated Adverse Events with Pimavanserin Treatment in Patients with Dementia-Related Psychosis. Presenting author: George Demos, M.D., Acadia Pharmaceuticals Inc.
    • Poster Presentation (P71): Comparative Efficacy, Safety, Tolerability, and Effectiveness of Antipsychotics in the Treatment of Dementia Related Psychosis (DRP): A Systematic Literature Review. Presenting author: Ismaeel Yunusa, An-L-lt-Iks, Inc.
    • Poster Presentation (P69): Mortality Risk and Use of Long-Term Custodial Care for Patients With Dementia and Psychosis Versus Patients With Dementia Only: A Longitudinal, Matched Cohort Analysis of Medicare Claims Data. Presenting author: Nazia Rashid, Acadia Pharmaceuticals Inc.

    About Pimavanserin

    Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. Acadia submitted a supplemental new drug application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis on June 3, 2020. The FDA has accepted for filing the sNDA for DRP with a PDUFA date of April 3, 2021. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialize the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Important Safety Information and Indication for NUPLAZID (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • Warnings and Precautions: QT Interval Prolongation
      • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

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  24. Acadia to Host Conference Call and Webcast on Wednesday, November 4, 2020, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report third quarter financial results on Wednesday, November 4, 2020, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on Wednesday, November 4, 2020, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 6266016). A telephone replay of the conference call may be accessed through November 18, 2020 by dialing 855-859-2056…

    Acadia to Host Conference Call and Webcast on Wednesday, November 4, 2020, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report third quarter financial results on Wednesday, November 4, 2020, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on Wednesday, November 4, 2020, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 6266016). A telephone replay of the conference call may be accessed through November 18, 2020 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 6266016). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com, under the investors section and will be archived there until December 2, 2020.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialize the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2019 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  25. The Lewy Body Dementia Association (LBDA) and Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) announced today an exclusive partnership on the production and release of a disease education adaptation of the new film Robin's Wish©, a documentary detailing the late actor Robin Williams' courageous battle with the neurodegenerative disorder, Lewy body dementia (LBD).

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201014005922/en/

    The film, SPARK - Robin Williams and his Battle with Lewy Body Dementia©, will go beyond describing LBD through the lens of Williams' personal experience and delve into the neurobiology of the disease and associated symptoms to help educate the medical community on…

    The Lewy Body Dementia Association (LBDA) and Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) announced today an exclusive partnership on the production and release of a disease education adaptation of the new film Robin's Wish©, a documentary detailing the late actor Robin Williams' courageous battle with the neurodegenerative disorder, Lewy body dementia (LBD).

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201014005922/en/

    The film, SPARK - Robin Williams and his Battle with Lewy Body Dementia©, will go beyond describing LBD through the lens of Williams' personal experience and delve into the neurobiology of the disease and associated symptoms to help educate the medical community on the second most common form of degenerative dementia. Lewy body dementia is also the most misdiagnosed dementia, and healthcare provider education is needed to enable early recognition, diagnosis and treatment.

    While the full-length film is available on demand and via digital channels, the adaptation, will be available to major academic research institutions and universities as part of educational programming and outreach to the healthcare professionals, the LBD community and general public. The film will be available starting in late October.

    "Robin Williams unknowingly battled LBD and unfortunately, he is not alone. This version of the documentary will not only raise awareness of Lewy body dementia, but reinforce the importance of early symptom recognition, diagnosis and effective management of this devastating disease, and can serve as a key element in our educational offering," said Todd Graham, Executive Director, Lewy Body Dementia Association.

    Approximately 8 million people in the United States are living with dementia, although only half are diagnosed with the condition.1,2,3 In addition to cognitive decline, neuropsychiatric symptoms, including hallucinations, delusions and changes in behavior, are also common. Lewy body dementia affects approximately 1.4 million people and their families in the United States alone.4

    "The use of scientific storytelling is an important opportunity to increase knowledge within the medical community on the need for better diagnostic and disease management solutions. Our goal is to ensure people struggling with LBD get the comprehensive support they need," said Ponni Subbiah, M.D., M.P.H., Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer at Acadia. "We are honored to partner with the LBDA and share a commitment to shine a light on the challenges that people with Lewy body dementia and their caregivers face."

    About Lewy Body Dementia Association

    The Lewy Body Dementia Association (LBDA) is the nation's leading authority on Lewy body dementias (LBD) and is dedicated to continuous outreach, education, research, and support for those affected with LBD and their families. LBD is a progressive brain disease that affects thinking, movement, behavior, and impacts 1.4 million people in the United States.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialize the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    References

    1 Plassman, BL Langa KM, Fisher GG, et al. Prevalence of dementia in the United States: the aging, demographics, and memory study. Neuroepidemiology. 2007;29(1-2):125-132.

    2 Goodman RA, Lochner KA, Thambisetty M, Wingo TS, Posner SF, Ling SM. Prevalence of dementia subtypes in United States Medicare fee-for-service beneficiaries, 2011-2013. Alzheimers Dement. 2017;13(1):28-37.

    3 Hebert LE, Weuve J, Scherr PA, Evans DA. Alzheimer disease in the United States (2010-2050) estimated using the 2010 census. Neurology. 2013;80(19):1778-1783.

    4 Lewy Body Dementia Association www.lbda.org.

    Copyright 2020 by Tiburon Sunrise, LLC

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  26. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the appointment of Elizabeth (Betsy) Garofalo, M.D. to its Board of Directors. Dr. Garofalo is a biopharma executive with more than 25 years of experience in global clinical development and regulatory affairs.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201001005364/en/

    Dr. Elizabeth Garofalo (Photo: Business Wire)

    Dr. Elizabeth Garofalo (Photo: Business Wire)

    "Dr. Garofalo is a highly-regarded business leader and innovator with invaluable clinical development experience," said Stephen R. Biggar, M.D., Ph.D., Chairman of Acadia's Board of Directors. "We are excited to welcome her to the Board of Directors and look forward to leveraging her significant CNS research and…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the appointment of Elizabeth (Betsy) Garofalo, M.D. to its Board of Directors. Dr. Garofalo is a biopharma executive with more than 25 years of experience in global clinical development and regulatory affairs.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201001005364/en/

    Dr. Elizabeth Garofalo (Photo: Business Wire)

    Dr. Elizabeth Garofalo (Photo: Business Wire)

    "Dr. Garofalo is a highly-regarded business leader and innovator with invaluable clinical development experience," said Stephen R. Biggar, M.D., Ph.D., Chairman of Acadia's Board of Directors. "We are excited to welcome her to the Board of Directors and look forward to leveraging her significant CNS research and development expertise, particularly as the company advances its innovative late stage and growing early stage pipeline."

    "I look forward to working with the talented Acadia management team as they continue to seek breakthroughs in the field of CNS, pioneering new research and developing innovative new therapies to address unmet needs," said Dr. Garofalo.

    Since 2016, Dr. Garofalo has served as the Principal for EAG Pharma Consulting LLC. Prior to that, Dr. Garofalo served in numerous leadership roles including as the Global Head of Clinical Development and member of the Novartis Global Development Leadership Team, Chair of the Novartis Portfolio Stewardship Board, Co-Head of the Novartis Neuroscience Franchise, Head of the Neuroscience Therapy Area at Astellas, Ann Arbor Site Head of Worldwide Regulatory Affairs at Pfizer, and Ann Arbor Site Head of Neuroscience at Pfizer.

    Dr. Garofalo currently serves on the board for the Institute for Advanced Clinical Trials in Children and is the Chair of the Business Advisory Board for the Epilepsy Foundation of America. She earned her M.D. from the Indiana University School of Medicine and completed fellowships in pediatric neurology and epilepsy at the University of Michigan Medical School.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life through science. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialize the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  27. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following upcoming virtual investor conferences:

    Citi 15th Annual BioPharma Virtual Conference
    Date: Wednesday, September 9, 2020
    Panel: Emerging Therapies for Psychiatric Disorders at 1:30 p.m. Eastern Time

    Morgan Stanley 18th Annual Global Healthcare Conference
    Date: Monday, September 14, 2020
    Fireside chat presentation: 3:45 p.m. Eastern Time

    Cantor Virtual Global Healthcare Conference
    Date: Wednesday, September 16, 2020
    Fireside chat presentation: 11:20 a.m. Eastern Time

    These conferences will all be held virtually. Live webcasts of the panel and presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following upcoming virtual investor conferences:

    Citi 15th Annual BioPharma Virtual Conference

    Date: Wednesday, September 9, 2020

    Panel: Emerging Therapies for Psychiatric Disorders at 1:30 p.m. Eastern Time

    Morgan Stanley 18th Annual Global Healthcare Conference

    Date: Monday, September 14, 2020

    Fireside chat presentation: 3:45 p.m. Eastern Time

    Cantor Virtual Global Healthcare Conference

    Date: Wednesday, September 16, 2020

    Fireside chat presentation: 11:20 a.m. Eastern Time

    These conferences will all be held virtually. Live webcasts of the panel and presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, ACP-044 for pain management and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

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  28. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the appointment of Dr. Gudarz Davar as Executive Vice President and Head of Research and Development. Dr. Davar will be responsible for leading research and development activities at ACADIA and will serve as a member of the company's Executive Management Committee. In this role, he will report to Serge Stankovic, M.D., M.S.P.H., President of ACADIA. Dr. Stankovic will continue to oversee research and development, regulatory, medical affairs, external innovation and pharmacovigilance functions for the company.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200831005180/en/

    Gudarz Davar, M.D., Executive Vice President and Head of Research and Development (Photo: Business Wire)

    Gudarz Davar, M.D., Executive Vice President and Head…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the appointment of Dr. Gudarz Davar as Executive Vice President and Head of Research and Development. Dr. Davar will be responsible for leading research and development activities at ACADIA and will serve as a member of the company's Executive Management Committee. In this role, he will report to Serge Stankovic, M.D., M.S.P.H., President of ACADIA. Dr. Stankovic will continue to oversee research and development, regulatory, medical affairs, external innovation and pharmacovigilance functions for the company.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200831005180/en/

    Gudarz Davar, M.D., Executive Vice President and Head of Research and Development (Photo: Business Wire)

    Gudarz Davar, M.D., Executive Vice President and Head of Research and Development (Photo: Business Wire)

    "We are thrilled to welcome Gudarz to ACADIA's executive team as a senior neurologist and neuroscientist with strong scientific, academic and corporate leadership experience," said Steve Davis, ACADIA's Chief Executive Officer. "As we prepare for the potential approval and launch in the U.S. of our second indication for pimavanserin, the treatment of hallucinations and delusions associated with dementia-related psychosis, we continue to focus on developing innovative new treatments to address unmet needs. Gudarz will be a valuable addition to our executive team as we execute and grow our pipeline to drive long-term growth."

    "I share ACADIA's passion for improving the lives of patients with central nervous system disorders and am particularly excited to use my experience to strengthen the breadth and depth of ACADIA's pipeline," said Dr. Davar.

    Dr. Davar joins ACADIA from Eli Lilly where he was Vice President, Head of Global Neurology Clinical Development, the senior leadership role responsible for the global development of all neuroscience and core Lilly biomedicines assets through clinical testing and life of the product. Under his leadership were the recent global approvals of Emgality® for migraine prevention and U.S. approval for the treatment of cluster headache, as well as the U.S. approval of REYVOW® as a first-in-class, novel, acute treatment for migraine.

    Prior to Eli Lilly, he served in senior leadership roles in neurology and clinical development at Allergan, Biogen Idec and Amgen. At Allergan, he led a global research and development and commercialization partnership focused on cognitive impairment and neurobehavioral symptoms in Alzheimer's disease.

    Dr. Davar received his medical degree from Dalhousie University in Halifax, Nova Scotia. He completed residency at University of Michigan Hospitals, Ann Arbor, Michigan and is board certified in Neurology.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, ACP-044 for pain management and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  29. - First-in-class, non-opioid, mechanism interrupts pain pathways

    - Phase 2 initiation planned for the first half of 2021

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the acquisition of CerSci Therapeutics, a clinical-stage biotechnology company with worldwide rights to a portfolio of novel compounds for neurological conditions, including non-opioid therapies for acute and chronic pain. The lead development program is a unique Reactive Species Decomposition Accelerant (RSDAx), a first-in-class mechanism focused on interrupting pathways that sensitize neurons to pain. The portfolio contains additional preclinical stage molecules, including brain penetrant molecules, with potential for symptomatic and disease modifying treatment…

    - First-in-class, non-opioid, mechanism interrupts pain pathways

    - Phase 2 initiation planned for the first half of 2021

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the acquisition of CerSci Therapeutics, a clinical-stage biotechnology company with worldwide rights to a portfolio of novel compounds for neurological conditions, including non-opioid therapies for acute and chronic pain. The lead development program is a unique Reactive Species Decomposition Accelerant (RSDAx), a first-in-class mechanism focused on interrupting pathways that sensitize neurons to pain. The portfolio contains additional preclinical stage molecules, including brain penetrant molecules, with potential for symptomatic and disease modifying treatment utility in neurodegenerative diseases.

    This acquisition strengthens ACADIA's clinical pipeline to include non-opioid pain therapies that have potential non-addictive properties and reduced side effects typically seen with current opioid treatments. The lead molecule, ACP-044, has shown promising efficacy and safety results in animal models evaluating incisional, inflammatory, and neuropathic pain, as well as favorable tolerability and pharmacokinetic properties in Phase 1 trials. The novel RSDAx mechanism of action is thought to interfere with multiple pain pathways treating pain simultaneously. ACADIA plans to initiate a Phase 2 clinical study in the first half of 2021.

    "There is an urgent need for new approaches to treat pain without causing addiction," said Steve Davis, ACADIA's Chief Executive Officer. "We are excited by the potential clinical utility of this program across multiple pain modalities due to its novel non-opioid mechanism of action. By acquiring CerSci, ACADIA is further strengthening our development pipeline for long-term growth in central nervous system disorders."

    "For too long, the options for patients with acute and chronic pain have been very limited," said Lucas Rodriguez, CEO and co-founder of CerSci. "I am highly confident that ACADIA, with its proven development and commercialization capabilities, can advance CerSci's program and ultimately deliver a new generation of medicines to treat acute post-operative as well as chronic pain conditions."

    Under the terms of the agreement, ACADIA acquired all of the outstanding shares of CerSci for $52.5 million, primarily in ACADIA stock. The transaction closed on August 24, 2020. CerSci shareholders may also receive up to $887 million in development, commercialization, and sales milestones in addition to tiered royalties in the mid-single digits based on annual net sales.

    BofA Securities is serving as financial advisor and Paul Hastings, LLP is serving as legal advisor to ACADIA. Evercore is serving as financial advisor and Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor to CerSci. CerSci's major investors include JDH Investment Management, LLC, Hiawatha Education Foundation, Lennox Capital Partners, LP and West Summit Investments, LP.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, ACP-044 for pain management and an early-stage muscarinic receptor program. ACADIA submitted a supplemental new drug application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis on June 3, 2020. The FDA has accepted for filing the sNDA for DRP with a PDUFA date of April 3, 2021. Pimavanserin is not approved for dementia-related psychosis. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the discovery, development and commercialization of any compounds from the above described acquisition, the clinical potential of and therapeutic opportunity for products based on such compounds and other statements that are not historical facts. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  30. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at The JMP Securities CNS Forum on Wednesday, August 19, 2020, at 11:00 a.m. Eastern Time.

    The conference will be held virtually. A live webcast of ACADIA's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through September 19, 2020.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at The JMP Securities CNS Forum on Wednesday, August 19, 2020, at 11:00 a.m. Eastern Time.

    The conference will be held virtually. A live webcast of ACADIA's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through September 19, 2020.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

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  31. - 2Q20 Net Sales of $110.1 Million, a 32% Increase Over 2Q19

    - FDA filed the supplemental NDA for pimavanserin for the treatment of dementia-related psychosis with a PDUFA action date set for April 3, 2021

    - Initiated ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the second quarter ended June 30, 2020.

    "In the first half of 2020 we drove robust growth of NUPLAZID®. With the FDA filing of our sNDA for dementia-related psychosis…

    - 2Q20 Net Sales of $110.1 Million, a 32% Increase Over 2Q19

    - FDA filed the supplemental NDA for pimavanserin for the treatment of dementia-related psychosis with a PDUFA action date set for April 3, 2021

    - Initiated ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the second quarter ended June 30, 2020.

    "In the first half of 2020 we drove robust growth of NUPLAZID®. With the FDA filing of our sNDA for dementia-related psychosis we are one step closer to potentially delivering the first and only approved treatment for this devastating condition," said Steve Davis, ACADIA's Chief Executive Officer. "Building upon the successful development of our PDP and DRP programs, our clinical team is focused on advancing our innovative early- and late-stage pipeline."

    Company Updates

    • The U.S. Food and Drug Administration (FDA) filed the supplemental NDA for pimavanserin for the treatment of the hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA has assigned a PDUFA (Prescription Drug User Fee Act) action date of April 3, 2021.
    • ACADIA announced top-line results from the Phase 3 CLARITY study of pimavanserin for adjunctive treatment in patients with major depressive disorder. The study did not achieve statistical significance on the primary endpoint which was the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.
    • ACADIA initiated its second pivotal study, ADVANCE-2, a 26-week, placebo-controlled, 386 patient Phase 3 study designed to evaluate the efficacy and safety of the 34 mg dose of pimavanserin for the treatment of the negative symptoms of schizophrenia.
    • ACADIA presented important clinical data at recent virtual medical congresses:
      • In May, at the 2020 American Society of Clinical Psychopharmacology virtual annual meeting, ACADIA presented six posters and an oral presentation on the positive pivotal ADVANCE study results, titled ADVANCE: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients with Negative Symptoms of Schizophrenia.
      • In July, at the 2020 Alzheimer's Association International Conference virtual event, ACADIA presented nine posters and an oral presentation on the positive findings from the open-label portion of the HARMONY study, titled HARMONY: Response to Pimavanserin in the 12-Week, Open-label Treatment Phase.
    • ACADIA appointed Mark Schneyer as Senior Vice President, Business Development and Chief Business Officer and appointed Spyros Papapetropoulos, M.D., Ph.D., as Senior Vice President, Head of Clinical Development.

    Financial Results

    Revenue

    Net sales of NUPLAZID (pimavanserin) were $110.1 million for the three months ended June 30, 2020, an increase of 32% as compared to $83.2 million reported for the three months ended June 30, 2019. For the six months ended June 30, 2020 and 2019, ACADIA reported net product sales of $200.2 million and $146.2 million, respectively.

    Research and Development

    Research and development expenses for the three months ended June 30, 2020 were $64.3 million, compared to $67.3 million for the same period of 2019. The decrease in the three month period ending June 2020 compared to June 2019 was primarily due to lower development costs for pimavanserin in schizophrenia and DRP. For the six months ended June 30, 2020 and 2019, research and development expenses were $136.9 million and $120.2 million, respectively. The increase during the six month period ending June 2020 compared to June 2019 was primarily due to an upfront payment of $10.0 million to Vanderbilt University for the M1 PAM program and increased development costs associated with trofinetide, offset by decreased development costs for pimavanserin in schizophrenia and DRP.

    Selling, General and Administrative

    Selling, general and administrative expenses for the three months ended June 30, 2020 were $84.3 million, compared to $68.0 million for the same period of 2019. For the six months ended June 30, 2020 and 2019, selling, general and administrative expenses were $186.3 million and $161.1 million, respectively. The increase during the 2020 periods as compared to 2019 was primarily due to increased advertising and promotional costs as well as an increase in personnel and related costs.

    Net Loss

    For the three months ended June 30, 2020, ACADIA reported a net loss of $42.1 million, or $0.27 per common share, compared to a net loss of $54.9 million, or $0.38 per common share, for the same period in 2019. The net losses for the three months ended June 30, 2020 and 2019 included $19.5 million and $20.4 million, respectively, of non-cash stock-based compensation expense. For the six months ended June 30, 2020, ACADIA reported a net loss of $130.2 million, or $0.83 per common share, compared to a net loss of $140.2 million, or $0.97 per common share, for the same period in 2019. The net losses for the six months ended June 30, 2020 and 2019 included $41.9 million and $40.3 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At June 30, 2020, ACADIA's cash, cash equivalents, and investment securities totaled $658.6 million, compared to $697.4 million at December 31, 2019.

    2020 Financial Guidance

    • NUPLAZID net sales guidance is updated to $430 to $450 million from the previous range of $420 to $450 million.
    • GAAP R&D guidance is decreased to $265 to $280 million from the previous range of $270 to $285 million.
    • GAAP SG&A guidance is decreased to $400 to $420 million from the previous range of $425 to $445 million.
    • Non-cash stock-based compensation expense guidance of $90 to $100 million is unchanged compared to prior guidance.
    • 2020 year-end cash, cash equivalents, and investment securities is expected to be $570 to $590 million from a previous range of $470 to $500 million.

    Conference Call and Webcast Information

    ACADIA management will review its second quarter financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9828845). A telephone replay of the conference call may be accessed through August 19, 2020 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9828845). The conference call also will be webcast live on ACADIA's website, www.acadia-pharm.com, under the investors section and will be archived there until September 2, 2020.

    About NUPLAZID® (pimavanserin)

    NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not FDA-approved for any other neuropsychiatric disorders. ACADIA discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; unanticipated impacts of COVID-19 on ACADIA's business, including its commercial sales operations, current and planned clinical trials, supply chain, and guidance for full-year 2020 NUPLAZID net sales and certain expense line items. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2020, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

     

     

     

    Three Months Ended June 30,

     

    Six Months Ended June 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenues

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    110,103

     

     

    $

    83,205

     

     

    $

    200,171

     

     

    $

    146,164

     

    Total revenues

     

     

    110,103

     

     

     

    83,205

     

     

     

    200,171

     

     

     

    146,164

     

    Operating expenses

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties (1)

     

     

    5,474

     

     

     

    4,995

     

     

     

    10,448

     

     

     

    9,575

     

    Research and development (1)

     

     

    64,295

     

     

     

    67,320

     

     

     

    136,931

     

     

     

    120,243

     

    Selling, general and administrative (1)

     

     

    84,344

     

     

     

    67,981

     

     

     

    186,317

     

     

     

    161,071

     

    Total operating expenses

     

     

    154,113

     

     

     

    140,296

     

     

     

    333,696

     

     

     

    290,889

     

    Loss from operations

     

     

    (44,010

    )

     

     

    (57,091

    )

     

     

    (133,525

    )

     

     

    (144,725

    )

    Interest income, net

     

     

    1,825

     

     

     

    2,527

     

     

     

    4,814

     

     

     

    5,461

     

    Other income (expense)

     

     

    437

     

     

     

    (12

    )

     

     

    (1,060

    )

     

     

    (241

    )

    Loss before income taxes

     

     

    (41,748

    )

     

     

    (54,576

    )

     

     

    (129,771

    )

     

     

    (139,505

    )

    Income tax expense

     

     

    393

     

     

     

    365

     

     

     

    393

     

     

     

    740

     

    Net loss

     

    $

    (42,141

    )

     

    $

    (54,941

    )

     

    $

    (130,164

    )

     

    $

    (140,245

    )

    Net loss per common share, basic and diluted

     

    $

    (0.27

    )

     

    $

    (0.38

    )

     

    $

    (0.83

    )

     

    $

    (0.97

    )

    Weighted average common shares outstanding, basic and diluted

     

     

    156,535

     

     

     

    144,314

     

     

     

    155,951

     

     

     

    144,148

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    (1) Includes the following stock-based compensation expense

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties

     

    $

    743

     

     

    $

    803

     

     

    $

    1,592

     

     

    $

    1,798