Acadia Pharmaceuticals Inc. · NASDAQ:ACAD
Acadia Pharmaceuticals — Q2 2021 Earnings Presentation
26 slides from Acadia Pharmaceuticals's earnings presentation, Aug 4, 2021
Slide 1: Second Quarter 2021 Earnings Call
Second Quarter 2021 Earnings Call August 4, 2021
Slide 2: 2Q21 Earnings Call Agenda
2Q21 Earnings Call Agenda Introduction Mark Johnson | Vice President, Investor Relations CEO Opening Remarks Steve Davis | Chief Executive Officer Amanda Morgan | Chief Revenue and Customer Officer Commercial Update Charmaine Lykins | Global Product Planning and Chief Marketing Officer R&D Update Se
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: Drive Growth of NUPLAZID in PDP
Drive Growth of NUPLAZID® in PDP 2Q21 • Delivered net sales of $115.2M, increase of 5% YoY • Driven by YoY and sequential volume growth • PD office visits and LTC occupancy below pre-pandemic levels FY21 • Revised FY21 sales guidance to $480M to $515M • Slower pace of recovery due to continued impac
Slide 6: Deliver on the DRP Opportunity: Key Takeaways from FDA Type A Meeting
Deliver on the DRP Opportunity: Key Takeaways from FDA Type A Meeting Key Takeaways: • FDA reiterated their stated position in the CRL that pimavanserin should be studied by individual subgroups of dementia • FDA advised that the best path forward is to conduct an additional clinical study in each o
Slide 7: Develop Next Wave of Breakthroughs
Develop Next Wave of Breakthroughs 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 Osteoa
Slide 8: Commercial Update
Commercial Update Amanda Morgan Chief Revenue and Customer Officer Charmaine Lykins Global Product Planning and Chief Marketing Officer
Slide 9: Office-based Channel Growth Dynamics
Office-based Channel Growth Dynamics Avg Monthly PD Patient Visits (IQVIA)1 NUPLAZID® New Patient Starts ~10% to 20% lower vs. 4Q19 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 Office-Based Channel: • Continuing patients maintained high fulfillment rates • PD patient office
Slide 10: Long-Term Care Channel Growth Dynamics
Long-Term Care Channel Growth Dynamics LTC Occupancy Rates1 Long-Term Care Channel: 83% • New admission rates and LTC occupancy levels slowly improving (0.5% to 1% per month)1 70% 71% 70% 68% 69% 68% • Occupancy and new admissions rates still below pre-pandemic levels 2019 Monthly Avg. Jan-21 Feb-21
Slide 11: NUPLAZID Message Platform
NUPLAZID® Message Platform Less than of patients with “Real improvement without 50% PD Psychosis patients receive impacting motor function” treatment ➢ Relevant messaging to the challenges of psychosis in Parkinson’s patients motivates HCPs to treat of physicians 37% say they delay treating PD Psych
Slide 12: Driving Long-term Growth in PDP
Driving Long-term Growth in PDP ➢ Drive new patient identification and new patient starts Marketing ➢ Promotional messaging prioritizes efficacy and safety of NUPLAZID®, symptom identification, and the urgency to treat early Medical HCPs attended a branded Congresses >2,000 NUPLAZID program in 2Q Pa
Slide 13: R&D Update
R&D Update Serge Stankovic President
Slide 14: Key Takeaways from FDA Type A Meeting
Key Takeaways from FDA Type A Meeting Key Takeaways: • FDA reiterated their stated position in the CRL that pimavanserin should be studied by individual subgroups of dementia • FDA advised that the best path forward is to conduct an additional clinical study in each of the subgroups for which we see
Slide 15: Publication of Positive HARMONY Results in The New England Journal of Medicine
Publication of Positive HARMONY Results in The New England Journal of Medicine1 HARMONY Study Results: • In the 12-week open-label portion, pimavanserin treatment showed a sustained reduction of psychotic symptoms • In 26-week double-blind portion, continuation of pimavanserin treatment significantl
Slide 16: 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 17: 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 18: ACP-044 for the Treatment of Acute and Chronic Pain
ACP-044 for the Treatment of Acute and Chronic Pain ACP-044 Mechanism of Action: Phase 2 Program • A novel, first-in-class, orally administered, non-opioid analgesic • Interrupts multiple pain pathways and sensitization of neurons to pain, by accelerating the decomposition of peroxynitrite, a nitrox
Slide 19: ACP-319 for the Treatment of 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) • Plan to initiate Phase 1 multiple ascending dose • Targets muscarinic (M1) receptors (MAD)
Slide 20: Development Timelines
Development Timelines Expected Compound Indication Milestone Timing Chronic Pain ACP-044 (Osteoarthritis) ✓ Initiated Phase 2 Study 2Q21 Acute Pain ACP-044 (Bunionectomy) Top-line Results: Phase 2 Study 4Q21 Trofinetide Rett Syndrome Top-line Results: Phase 3 LAVENDER Study 4Q21 Schizophrenia and AC
Slide 21: Finance Update
Finance Update Elena Ridloff Chief Financial Officer
Slide 22: 2Q21 Financial Highlights
2Q21 Financial Highlights 2Q21 2Q20 Millions, Except EPS YoY Change (GAAP) (GAAP) Total Revenue $115.2 $110.1 +5% Cost of Product Sales, License Fees and Royalties $5.2 $5.5 -5% R&D $56.9 $64.3 -11% SG&A $96.8 $84.3 +15% Net Loss $43.9 $42.1 +4% EPS ($0.27) ($0.27) - Cash Balance1 $556.9 1Cash balan
Slide 23: FY2021 Financial Guidance
FY2021 Financial Guidance Previous Guidance Updated Guidance FY 2021 Commentary (5/5/2021) (8/4/2021) Reduced guidance due to continued impacts of the COVID-19 pandemic NUPLAZID® Net Sales $510 to $550M $480M - $515M and gross-to-net of ~20% vs. prior expectations of high teens GAAP R&D Expense $280
Slide 24: CEO Closing Remarks
CEO Closing Remarks Steve Davis CEO
Slide 25: Building a Leading CNS Company
Building a Leading CNS Company 1 Significant long-term opportunity to grow NUPLAZID® in PDP 2 Ongoing discussions with FDA regarding pimavanserin for DRP 3 Near-term clinical data read-outs in the second half of 2021 NUPLAZID (pimavanserin) is only approved in the U.S. by the FDA for the treatment o
Slide 26: Q&A Session
() ACADIA Q&A Session
ACADIA Pharmaceuticals — Q2 2021 Earnings Presentation on 6ix