Full Press Release Details
Steve Davis, CEO 38th Annual J.P.
Morgan Healthcare Conference January 14, 2020 Exhibit 99.1
Forward-Looking Statement This
presentation contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially
different from any future results, performances or achievements expressed in or implied by such forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to
change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about (i) plans for, including timing and progress of commercialization of, NUPLAZID or for the clinical
development of our product candidates, including pimavanserin and trofinetide; (ii) benefits to be derived from and efficacy of our product candidates, including the use of pimavanserin in dementia-related psychosis, schizophrenia, depression
or other neurological or psychiatric indications, potential advantages of NUPLAZID versus existing antipsychotics or antidepressants, and expansion opportunities for NUPLAZID; (iii) estimates regarding the prevalence of PD, PD Psychosis,
dementia-related psychosis, schizophrenia or depression and the potential use of trofinetide in Rett syndrome; (iv) potential markets for any of our products, including NUPLAZID and trofinetide; and (v) our estimates regarding our future
financial performance, cash position or capital requirements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "could," "would,"
"expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "potential" and similar expressions (including the negative thereof)
intended to identify forward-looking statements. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of the risks and other factors that may cause our actual results,
performance or achievements to differ, please refer to our annual report on Form 10-K for the year ended December 31, 2018 as well as our subsequent filings with the SEC. The forward-looking statements contained herein are made as of the date
hereof, and we undertake no obligation to update them for future events. Provided January 14, 2020 as part of an oral presentation and is qualified by such; contains forward-looking statements; actual results may vary materially; ACADIA disclaims
Transforming standard of care for PDP
patients NUPLAZID net sales Growth YoY1 50% ACADIA in 2020 - Building a Leading CNS Platform Dedicated to Improving Lives of Patients, Families, and Caregivers Late-stage pipeline programs 3 Positive pivotal studies Innovative pipeline 4
Potential increase in addressable market beyond PDP2 35X Pimavanserin focused on significant patient need 12019 net sales guidance of $330-340M, represents a 50% increase in revenue and 38% volume growth year-over-year at the mid-point of the range.
2ACADIA Market Research based on estimated U.S. treated populations for patients with dementia-related psychosis (DRP), adjunctive treatment for major depressive disorder (MDD), and the negative symptoms of schizophrenia (NSS). Provided January 14,
2020 as part of an oral presentation and is qualified by such; contains forward-looking statements; actual results may vary materially; ACADIA disclaims any duty to update.
Successful Execution and Strong Balance
Sheet Position ACADIA for Significant Long-term Growth Drive NUPLAZID Growth in PDP Deliver DRP Opportunity to the Market Develop Innovative Treatments For Unmet Needs 2020 Strategic Pillars Provided January 14, 2020 as part of an oral
presentation and is qualified by such; contains forward-looking statements; actual results may vary materially; ACADIA disclaims any duty to update.
Safety in Late-Stage Clinical Trials
DRP - No negative impact on cognition or impairment of motor function MDD - Improved symptoms of sexual dysfunction with no increased sedation or weight gain Schizophrenia - No effect on vital signs, weight, and metabolic syndrome The Potential of
Pimavanserin A Novel Selective Serotonin Inverse Agonist 12030 reflects composition of matter patent including Hatch-Waxman patent term extension. NUPLAZID (pimavanserin) is only approved in the U.S by the FDA for the treatment of hallucinations and
delusions associated with Parkinson's disease psychosis. Provided January 14, 2020 as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; ACADIA disclaims any duty to
update. Current - NUPLAZID First and only FDA-approved treatment for PDP FDA Breakthrough Therapy Patent protection into 20301 Future - Pimavanserin Robust efficacy in pivotal studies across 3 additional CNS indications: DRP (FDA
Breakthrough Therapy) MDD (adjunctive treatment) Negative symptoms of schizophrenia
1 Pimavanserin - Robust and
Consistent Efficacy Across Four Disease Areas PDP: Pivotal -020 Study, p=0.0014 DRP: Pivotal HARMONY Study, p=0.0023 MDD: Pivotal CLARITY Study (Stage 1 only, p=0.00031) NSS: Pivotal ADVANCE Study (34 mg patients only, p=0.00652) 1Primary endpoint
was HAMD-17 total score compared to placebo (wgt. avg. of Stage 1 + 2) in a sequential parallel comparison design (p=0.039). Graph shows results from Stage 1. 2Pimary endpoint was NSA-16 total score at 26-weeks in patients that received either 20 mg
or 34 mg pimavanserin + background antipsychotic vs placebo + background antipsychotic (p=0.043). Graph shows results for patients that received the higher 34 mg dose. Provided January 14, 2020 as part of an oral presentation and is qualified by
such; contains forward-looking statements; actual results may vary materially; ACADIA disclaims any duty to update.
1ACADIA Market Research based on
estimated U.S. treated populations for patients with Parkinson's disease psychosis, dementia-related psychosis, adjunctive treatment for major depressive disorder, and the negative symptoms of schizophrenia. Provided January 14, 2020 as part
of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; ACADIA disclaims any duty to update. Parkinson's Disease Psychosis Negative Symptoms of Schizophrenia Dementia-Related
Psychosis Major Depressive Disorder (Adjunctive Therapy) ~125K ~700K ~1.2M ~2.5M Pimavanserin - Potential to Provide Meaningful Advances for Patients 5X 10X 20X U.S. Addressable Market Opportunities by Indication1 Approved sNDA Submission:
Summer 2020 CLARITY-2 Phase 3 Results: 4Q20 Second Pivotal Study: Commence Summer 2020
Develop Innovative Treatments For Unmet
Needs Drive NUPLAZID Growth in PDP Deliver DRP Opportunity to the Market 2020 Strategic Pillars Provided January 14, 2020 as part of an oral presentation and is qualified by such; contains forward-looking statements; actual results may vary
materially; ACADIA disclaims any duty to update.
12019 net sales guidance of $330-340M,
represents a 50% increase in revenue and 38% volume growth year-over-year at the mid-point of the range; *$335M represents mid-point of the range. 2"Update on Treatments for Non-motor Symptoms of Parkinson's Disease". Seppi et al.
Movement Disorders 2019 Volume 34, Issue 2;180-198. NUPLAZID (pimavanserin) is only approved in the U.S by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Provided January 14, 2020 as
part of an oral presentation and is qualified by such; contains forward-looking statements; actual results may vary materially; ACADIA disclaims any duty to update. Significant Future Growth Opportunity in PDP 2019 net sales guidance: $330-340M1
+50% revenue / +38% volume YoY High teens market penetration exiting 2019 Continued growth leveraging: MDS Evidence based guidelines2 NUPLAZID only therapy recognized as clinically useful and acceptable level of safety risk without specialized
monitoring New caregiver burden and long-term clinical safety data Digital and patient/caregiver campaigns Drive NUPLAZID Growth in Parkinson's Disease Psychosis
Drive NUPLAZID Growth in PDP
Deliver DRP Opportunity to the Market 2020 Strategic Pillars Develop Innovative Treatments For Unmet Needs Provided January 14, 2020 as part of an oral presentation and is qualified by such; contains forward-looking statements; actual results may
vary materially; ACADIA disclaims any duty to update.
1 Peluso MJ1, Lewis SW, Barnes TR,
Jones. Extrapyramidal motor side-effects of first- and second-generation antipsychotic drugs. Br J Psychiatry 2012 May;200(5):387-92. doi: 10.1192/bjp.bp.111.101485. Epub 2012 Mar 22. Schneider LS, Tariot PN, Dagerman KS, et al, CATIE-AD Study
Group. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med 2006; 355: 1525-38. Provided January 14, 2020 as part of an oral presentation and is qualified by such; contains forward-looking
statements; actual results may vary materially; ACADIA disclaims any duty to update. Deliver New Opportunity for Dementia-Related Psychosis Pimavanserin has Breakthrough Therapy Designation for the treatment of DRP Today, antipsychotics used
off-label1: Accelerate cognitive decline Impair motor function Cause extrapyramidal symptoms Increase sedation Cause orthostatic hypotension No FDA-approved treatments for DRP
392 Patients (50 - 90 years
old) Pimavanserin responders enter randomized, double-blind period Non-responders exit Primary Endpoint: Time to Relapse 12-Week (Open Label Period) ALL patients go on pimavanserin Placebo 26-Week Randomized (1:1) (Double-Blind Period) Pimavanserin
Phase 3 HARMONY Relapse Prevention Study in DRP NUPLAZID (pimavanserin) is only approved in the U.S by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Provided January 14, 2020 as part
of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; ACADIA disclaims any duty to update.
Achieved Meaningful Primary Endpoint
Pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold Hazard Ratio = 0.353 One-sided p-value = 0.0023 Strong Open-Label Efficacy Results 61.8% of eligible patients met the pre-specified response criteria at weeks 8 and 12
75.2% improvement from baseline on SAPS-H+D1 score at week 12 9-Month Safety and Tolerability Results Well-tolerated in chronic treatment of frail and elderly patients with significant comorbidities No worsening of cognition2 No worsening of motor
function3 1SAPS-H+D (Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions). As measured by MMSE (Mini-Mental State Examination)2 and ESRS-A (Extrapyramidal Symptom Rating Scale A) scores3. Data originally presented at CTAD 2019
on 12/4/2019. NUPLAZID (pimavanserin) is only approved in the U.S by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Provided January 14, 2020 as part of an oral presentation and is
qualified by such; contains forward-looking statements; actual results may vary materially; ACADIA disclaims any duty to update. Robust Positive Phase 3 HARMONY Results 3 2 1
Data originally presented at CTAD
2019 on 12/4/2019. NUPLAZID (pimavanserin) is only approved in the U.S by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Provided January 14, 2020 as part of an oral presentation and is
qualified by such; contains forward-looking statements; actual results may vary materially; ACADIA disclaims any duty to update. 2.8 Fold Reduction in Risk of Relapse of Psychosis Hazard Ratio = 0.353 One-sided p-value = 0.0023 Primary Endpoint:
Time to Relapse Relapse-free probability Double-blind
No Negative Impact on Cognition
(MMSE) Over 6 Months Compared to Placebo1 1[Mean +/- SE] (OC) DB safety dataset respectively. MMSE = Mini-Mental Status Examination, a test of cognitive function. Data originally presented at CTAD 2019 on 12/4/2019. NUPLAZID (pimavanserin) is only
approved in the U.S by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Provided January 14, 2020 as part of an oral presentation and is qualified by such; contains forward-looking
statements; actual results may vary materially; ACADIA disclaims any duty to update.
No Negative Impact on Cognition
(MMSE) Over 9 Months of Treatment1 1[Mean +/- SE] (OC) OL and DB safety dataset respectively. MMSE = Mini-Mental Status Examination, a test of cognitive function. Data originally presented at CTAD 2019 on 12/4/2019. NUPLAZID (pimavanserin) is only
approved in the U.S by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Provided January 14, 2020 as part of an oral presentation and is qualified by such; contains forward-looking
statements; actual results may vary materially; ACADIA disclaims any duty to update.
Positive Phase 3 HARMONY Study
Positive Phase 2 (019) Alzheimer's Disease Psychosis Study1 & Positive data in PDP (020) patients with dementia2 Pimavanserin has Breakthrough Therapy Designation for the Treatment of DRP 1Ballard C, et al. Lancet. 2018;17:213-222.
2NUPLAZID Prescribing Information; Cummings J, et al. Lancet. 2014;383:533-540. NUPLAZID (pimavanserin) is only approved in the U.S by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
Provided January 14, 2020 as part of an oral presentation and is qualified by such; contains forward-looking statements; actual results may vary materially; ACADIA disclaims any duty to update. Pre-sNDA meeting request submitted Plan to submit sNDA
in summer 2020 sNDA will include the following: Safety and Tolerability Data from Completed & Ongoing Studies DRP Next Steps Pivotal Efficacy Supportive Efficacy Large Safety Database
Drive NUPLAZID Growth in PDP
Deliver DRP Opportunity to the Market 2020 Strategic Pillars Develop Innovative Treatments For Unmet Needs Provided January 14, 2020 as part of an oral presentation and is qualified by such; contains forward-looking statements; actual results may
vary materially; ACADIA disclaims any duty to update.
COMPOUND/ PROGRAM INDICATION PHASE 1
PHASE 2 PHASE 3 MARKETED NUPLAZID (pimavanserin)1 Hallucinations and Delusions associated with PD Psychosis Pimavanserin Dementia-Related Psychosis Pimavanserin Major Depressive Disorder Adjunctive Therapy Trofinetide2 Rett Syndrome
Pimavanserin Negative Symptoms of Schizophrenia 1NUPLAZID (pimavanserin) is only approved in the U.S by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. 2ACADIA has an exclusive license
to develop and commercialize trofinetide in North America from Neuren Pharmaceuticals. Provided January 14, 2020 as part of an oral presentation and is qualified by such; contains forward-looking statements; actual results may vary materially;
ACADIA disclaims any duty to update. Innovative Late-Stage Pipeline
~17M patients in the U.S. have MDD1
Majority of patients with MDD do not respond to initial antidepressant therapy ~2.5M treated with adjunctive therapy2 Adjunctive use of existing antipsychotics can lead to significant side effects: Sexual dysfunction Sedation Weight gain Cognitive
impairment Extrapyramidal symptoms Rare but serious tardive dyskinesia 1National Institute of Mental Health. (2017). Major Depression. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml. 2IMS NSP, NPA, NDTI MAT-24 month
data through Aug-2017; PLOS One, Characterization of Treatment Resistant Depression Episodes in a Cohort of Patients from a US Commercial Claims Database, Oct 2013, Vol 8, Issue 10. Provided January 14, 2020 as part of an oral presentation and is
qualified by such; contains forward-looking statements; actual results may vary materially; ACADIA disclaims any duty to update. Major Depressive Disorder - Adjunctive Therapy High unmet need for differentiated adjunctive therapy
CLARITY-2 Phase 3 Study Results
Expected 4Q 2020 Two ongoing Phase 3 studies with only one additional positive study necessary for sNDA 1HAMD-17: 17-item Hamilton Depression Rating Scale; SDS = Sheehan Disability Scale. 2Week 1 separation from placebo observed in Stage 1 (n=207)
and Week 10 separation from placebo observed in Stage 1 patients who were not re-randomized in Stage 2 (n=174). NUPLAZID (pimavanserin) is only approved in the U.S by the FDA for the treatment of hallucinations and delusions associated with
Parkinson's disease psychosis. Provided January 14, 2020 as part of an oral presentation and is qualified by such; contains forward-looking statements; actual results may vary materially; ACADIA disclaims any duty to update. CLARITY Results
Meaningful Efficacy: Primary endpoint achieved - Depression1 HAMD-17 (p-value=0.039) Robust effect in the parallel design Stage 1 HAMD-17 (p-value = 0.0003; Effect size = 0.63) Key secondary endpoint achieved - Disability1 SDS (p-value=0.004)