Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q3 2021 Earnings Presentation
27 slides from Acadia Pharmaceuticals's earnings presentation, Nov 8, 2021
Slide 1: Third Quarter 2021 Earnings Call
Third Quarter 2021 Earnings Call November 8, 2021
Slide 2: 3Q21 Earnings Call Agenda
3Q21 Earnings Call Agenda Introduction Mark Johnson | Vice President, Investor Relations CEO Opening Remarks Steve Davis | Chief Executive Officer Commercial Update Brendan Teehan | Chief Operating Officer, Head of Commercial R&D Update Serge Stankovic, M.D., M.S.P.H | President Financial Update Mar
Slide 3: Forward-Looking Statements
Forward-Looking Statements 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 r
Slide 4: CEO Opening Remarks
CEO Opening Remarks Steve Davis CEO
Slide 5: NUPLAZID Growth in FY21
NUPLAZID® Growth in FY21 Net Sales (in millions) $140 $120 NUPLAZID Performance: $100 ✓ Delivered net sales of $131.6M in 3Q21 $80 ✓ YoY and QoQ growth despite pandemic $60 ✓ NUPLAZID continuing to outperform basket of other top brands in Neurology and $40 Parkinson’s disease across channels $20 ✓ S
Slide 6: Regulatory Update on Pimavanserin sNDA
Regulatory Update on Pimavanserin sNDA End of Review Meeting Follow-up Meeting (Complete) (Scheduled) • Acadia believes pimavanserin is best • Discuss with FDA potential studied in the broad dementia-related resubmission strategy without psychosis indication another clinical study • FDA prefers to e
Slide 7: Near-term Catalysts
Near-term Catalysts Regulatory update from FDA meeting on potential next steps to a 1 resubmission expected ~YE21 Phase 3 results from LAVENDER, evaluating trofinetide for 2 Rett syndrome, expected in 4Q21 Phase 2 results from a proof-of-concept study evaluating 3 ACP-044 for postoperative pain, exp
Slide 8: Commercial Update
Commercial Update Brendan Teehan Chief Operating Officer, Head of Commercial
Slide 9: Continued Strong Commercial Execution in PDP
Continued Strong Commercial Execution in PDP Office-based Channel: (3Q21 vs. 2019)1 Long-term Care Channel: (3Q21 vs. 2019)1 (TRX monthly average) (TRX monthly average) Strong Relative Performance NUPLAZID® +28% NUPLAZIDꝉ +8% Carbidopa / Levodopa -4% Carbidopa / Levodopa -12% Avg. Top 10 PD Brands -
Slide 10: NUPLAZID HCP Awareness Campaign
NUPLAZID® HCP Awareness Campaign Educating HCPs about: Improving PD psychosis symptoms without impacting motor function ➢ Relevant messaging to the challenges of psychosis in Parkinson’s patients motivates HCPs to treat Less than of PD patients with psychosis receive 50% treatment of physicians say
Slide 11: NUPLAZID Integrated Awareness Campaign
NUPLAZID® Integrated Awareness Campaign New Campaign: • Includes DTC television and digital ads to target patients and caregivers at home • Ads focus on disease awareness and potential of NUPLAZID as treatment Commercial Readiness: • Commercial team promoting to HCPs to prescribe new patients as the
Slide 12: R&D Update
R&D Update Serge Stankovic President
Slide 13: HARMONY: Alzheimer's Disease Subgroup
HARMONY: Alzheimer’s Disease Subgroup HARMONY Study1 Pimavanserin showed consistent and clinically meaningful reduction in risk of psychosis relapse in AD subgroup (~40% reduction) Overall AD Subgroup Examples of analyses for HARMONY Open-label portion of study (12 weeks) supporting antipsychotic ef
Slide 14: Alzheimer's Disease Psychosis Study -019
Alzheimer’s Disease Psychosis Study -0191,2 Primary Endpoint Responder Analyses Improvement in NPI-NH PS over 6 weeks Percent Improvement in NPI-NH PS over 6 weeks Subjects w/ NPI-NH PS ≥ 12 Primary Endpoint (at baseline) Placebo Pimavanserin Placebo Pimavanserin N 81 76 25 27 MMRM -1.93 (0.634) -3.
Slide 15: Trofinetide for the Treatment of Rett Syndrome
Trofinetide for the Treatment of Rett Syndrome Trofinetide MOA: Phase 2 Study Results3 Novel synthetic analog of amino‐terminal tripeptide of IGF-1 with potential to reduce neuroinflammation and • 6-week, placebo-controlled dose ranging study in support synaptic function 82 young females (ages 5 – 1
Slide 16: Pimavanserin for the Treatment of the Negative Symptoms of Schizophrenia
Pimavanserin for the Treatment of the Negative Symptoms of Schizophrenia High Unmet Need1: ADVANCE-1 Results2 • No FDA-approved treatment for the negative • 26-week pivotal study in 403 patients with symptoms of schizophrenia predominant negative symptoms3 • >700K patients receiving treatment in the
Slide 17: ACP-044 Phase 2 Study for Postoperative Pain
ACP-044 Phase 2 Study for Postoperative Pain First in Class Redox Modulator for Pain: Preclinical Evidence • Tissue injury or disease can increase formation of reactive oxygen and nitrogen species (ROS/RNS), initiating redox signaling pathways that result in pain1,2 • In postoperative pain models, A
Slide 18: ACP-319 for Schizophrenia and Cognitive Impairment in Alzheimer's Disease
ACP-319 for the Treatment of Schizophrenia and Cognitive Impairment in Alzheimer’s Disease ACP-319 Mechanism of Action: ACP-319 Development Status • Positive Allosteric Modulator of the M1 receptor (M1 PAM) • Targets muscarinic (M1) receptors • Phase 1 multiple ascending dose study initiated • Chall
Slide 19: Program Development Pipeline
Program Development Pipeline Program Indication Phase 1 Phase 2 Phase 3 Marketed NUPLAZID® Parkinson’s Disease (pimavanserin)1 Psychosis Dementia-Related Pimavanserin2 Psychosis Negative Symptoms of Pimavanserin Schizophrenia Trofinetide3 Rett Syndrome ACP-044 Postoperative Pain ACP-044 Osteoarthrit
Slide 20: Finance Update
Finance Update Mark Schneyer Interim Chief Financial Officer
Slide 21: 3Q21 Financial Highlights
3Q21 Financial Highlights Millions, Except EPS 3Q21 3Q20 YoY Change (GAAP) (GAAP) Total Revenue $131.6 $120.6 +9% R&D $58.6 $120.1 -51% SG&A $81.7 $81.6 0% Net Loss $14.5 $84.7 -83% EPS ($0.09) ($0.54) +83% Cash Balance1 $540.3 1Cash balance includes cash, cash equivalents and investments as of 9/30
Slide 22: FY2021 Financial Guidance
FY2021 Financial Guidance Previous Guidance Updated Guidance FY2021 Commentary (8/4/2021) (11/8/2021) NUPLAZID® Net Sales $480 to $515M $480 to $500M Narrowed top-end of guidance Includes ~$25M of stock-based GAAP R&D Expense $250 to $270M $230 to $245M compensation expense Includes ~$45M of stock-b
Slide 23: Continued Strong Commercial Execution in PDP
Continued Strong Commercial Execution in PDP Office-based Channel: (3Q21 vs. 2019)1 Long-term Care Channel: (3Q21 vs. 2019)1 (TRX monthly average) (TRX monthly average) Strong Relative Performance NUPLAZID® +28% NUPLAZIDꝉ +8% Carbidopa / Levodopa -4% Carbidopa / Levodopa -12% Avg. Top 10 PD Brands -
Slide 24: FY2021 Financial Guidance
FY2021 Financial Guidance Previous Guidance Updated Guidance FY2021 Commentary (8/4/2021) (11/8/2021) NUPLAZID® Net Sales $480 to $515M $480 to $500M Narrowed top-end of guidance Includes ~$25M of stock-based GAAP R&D Expense $250 to $270M $230 to $245M compensation expense Includes ~$45M of stock-b
Slide 25: CEO Closing Remarks
CEO Closing Remarks Steve Davis CEO
Slide 26: Near-term Catalysts
Near-term Catalysts Regulatory update from FDA meeting on potential next steps to a 1 resubmission expected ~YE21 Phase 3 results from LAVENDER, evaluating trofinetide for 2 Rett syndrome, expected in 4Q21 Phase 2 results from a proof-of-concept study evaluating 3 ACP-044 for postoperative pain, exp
Slide 27: Q&A Session
() ACADIA Q&A Session
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