Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — 38th Annual J.P. Morgan Healthcare Conference 2020
27 slides from Acadia Pharmaceuticals's conference presentation, Jan 13, 2020
Slide 1: 38th Annual J.P. Morgan Healthcare Conference
Steve Davis, CEO 38th Annual J.P. Morgan Healthcare Conference January 14, 2020 Exhibit 99.1
Slide 2: Forward-Looking Statement
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 re
Slide 3: Building a Leading CNS Platform
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 a
Slide 4: 2020 Strategic Pillars
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 qua
Slide 5: The Potential of Pimavanserin
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
Slide 6: Robust and Consistent Efficacy Across Four Disease Areas
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
Slide 7: Potential to Provide Meaningful Advances for Patients
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 a
Slide 8: 2020 Strategic Pillars
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
Slide 9: Significant Future Growth Opportunity in PDP
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
Slide 10: 2020 Strategic Pillars
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
Slide 11: Deliver New Opportunity for Dementia-Related Psychosis
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
Slide 12: Phase 3 HARMONY Relapse Prevention Study in 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
Slide 13: Achieved Meaningful Primary Endpoint
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% improveme
Slide 14: 2.8 Fold Reduction in Risk of Relapse of Psychosis
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; con
Slide 15: No Negative Impact on Cognition (MMSE) Over Months Compared to Placebo
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
Slide 16: No Negative Impact on Cognition (MMSE) Over Months of Treatment
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
Slide 17: DRP Next Steps
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; Cu
Slide 18: 2020 Strategic Pillars
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
Slide 19: Innovative Late-Stage Pipeline
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 Symptom
Slide 20: Major Depressive Disorder – Adjunctive Therapy
~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 Extra
Slide 21: CLARITY-2 Phase 3 Study Results Expected 4Q 2020
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 separati
Slide 22: Negative Symptoms of Schizophrenia
~40 - 50% of schizophrenia patients experience predominant negative symptoms1 Negative symptoms include apathy, lack of emotion, social withdrawal, restricted speech, and blunted affect and can lead to: Low social functioning Long-term disability Significant caregiver burden 1Studies suggest that ~4
Slide 23: Summary of Top-line ADVANCE Results
1NSA-16: Negative Symptom Assessment-16. 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 forwar
Slide 24: Trofinetide for the Treatment of Rett Syndrome
Debilitating neurologic rare disease 6,000 to 9,000 patients in the U.S.1 Symptoms manifest primarily in young females: Cognitive, sensory, emotional, and motor impairment Loss of independence Loss of purposeful hand use Loss of spoken communication 1U.S. prevalence estimate based on incidence rates
Slide 25: Trofinetide Clinical Program
LAVENDER Phase 3 study ongoing: ~180 females (ages 5 – 20) with Rett syndrome Double-blind, placebo-controlled Co-primary endpoints: RSBQ and CGI-I 12-week study duration LILAC 9-month extension study: To evaluate LT tolerability and safety of trofinetide RSBQ = Rett Sydnrome Behaviour Questionnaire
Slide 26: Upcoming Clinical and Regulatory Milestones
Upcoming Clinical and Regulatory Milestones 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 for
Slide 27: Improving lives for patients, caregivers and families
Improving lives for patients, caregivers and families
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