First Quarter 2024 Earnings Call
May 8, 2024
Call Agenda
Welcome
CEO Opening Remarks
Commercial Update
R&D Update
Financial Update
Closing Remarks
Q&A Session
Al Kildani | Senior Vice President, Investor Relations and Corporate Communications
Steve Davis | President and Chief Executive Officer
Brendan Teehan | Chief Operating Officer, Head of Commercial
Kimberly Manhard | Senior Vice President, Global Strategic Planning and Execution
Mark Schneyer | Chief Financial Officer
Steve Davis | President and Chief Executive Officer
Parag Meswani, Pharm D. | Senior Vice President, Trofinetide - Rare Disease Franchise, available for Q&A
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Forward-Looking Statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "outlook," "potential" and similar expressions (including the negative thereof) intended to identify
forward-looking statements. Forward-looking statements contained in this presentation, include, but are not limited to, statements about: (i) our business strategy, objectives and opportunities; (ii) plans for, including timing, development and progress of commercialization or regulatory timelines for, NUPLAZID, DAYBUE and our product candidates; (iii) benefits to be derived from and efficacy of our products, including the potential advantages of NUPLAZID and DAYBUE and expansion opportunities for NUPLAZID and DAYBUE in other indications, and for DAYBUE in jurisdictions outside the U.S.; (iv) estimates regarding the prevalence of the diseases targeted by our products and product candidates; (v) potential markets for any of our commercial products; and (vi) our estimates regarding our future financial performance, cash position, profitability or capital requirements.
Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our dependency on the continued successful commercialization of NUPLAZID and DAYBUE and our ability maintain or increase sales of NUPLAZID or DAYBUE; the costs of our commercialization plans and development programs, and the financial impact or revenues from any commercialization we undertake; our ability to obtain necessary regulatory approvals for our product candidates and, if and when approved, market acceptance of our products; our dependence on third-party collaborators, clinical research organizations, manufacturers, suppliers and distributors; the impact of competitive products and therapies; our ability to generate or obtain the necessary capital to fund our operations; our ability to grow, equip and train our specialized sales forces; our ability to manage the growth and complexity of our organization; our ability to maintain, protect and enhance our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties 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, 2023 as well as our subsequent filings with the Securities and Exchange Commission from time to time, including our quarterly report on Form 10-Q for the period ended March 31, 2024. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.
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Opening
Remarks
Steve Davis, President and Chief Executive Officer
Acadia Investment Thesis
Two successful
commercial franchises
$205.8M in Q1 2024 revenues
- NUPLAZID® $129.9M
- DAYBUE™ $75.9M
Two late-stage assets with strong early-stage pipeline
Ongoing P3 trial of ACP-101 in Prader-Willi syndrome
Ongoing seamless P2 / P3 program of ACP-204 in Alzheimer's disease psychosis
Numerous early-stage programs
Financial strength
74% YoY revenue growth in 1Q24
Cash balance of $470.5M as of March 31, 2024
DAYBUE (trofinetide) is only approved in the U.S. by the FDA for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. | 5 |
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. | |
DAYBUE Overview
DAYBUE Today
- 5,000 diagnosed population
- 25% penetration to date
- Persistency continues to track ~10 percentage points above clinical experience
- Average dose (post titration) remains ~75-80%
- >650 prescribers to date
- Broad payor access
DAYBUE Outlook
- Sizeable untreated population
- Growing body of real-world benefits
- Facilitate consistent application of GI
management strategies
- Drive depth of prescribing outside of COEs
- Continue net patient growth
- Net patient adds in each of last six weeks
6
Deep CNS Pipeline
Program | Indication | Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed |
NUPLAZID® | Parkinson's Disease | |||||
(pimavanserin) | Psychosis | |||||
DAYBUE™ | Rett Syndrome | |||||
(trofinetide) | ||||||
ACP-1011,2 | Hyperphagia in | |||||
Prader-Willi Syndrome | ||||||
ACP-2042 | Alzheimer's Disease | |||||
Psychosis | ||||||
ACP-25912 | Rett Syndrome; Fragile | |||||
X Syndrome | ||||||
ASO Programs2 | SYNGAP1; Rett | |||||
syndrome; Undisclosed | ||||||
Multiple Undisclosed | Neuropsychiatric and | |||||
Programs | Rare Disorders |
1 Acadia acquired Levo Therapeutics and its rights/licenses to ACP-101. | |
2 The safety and efficacy of these investigational agents have not been established. There is no guarantee these investigational agents will be filed with or approved by any regulatory agency. | |
DAYBUE (trofinetide) is only approved in the U.S. by the FDA for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. | 7 |
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. | |
Commercial
Update
Brendan Teehan, Chief Operating Officer, Head of Commercial
Key Drivers of Long-Term Value for DAYBUE
1 out of 4 diagnosed Rett patients have received treatment with DAYBUE; large remaining untreated patient population
• Successfully penetrated COEs; now have ~50% share of patients treated
- Driving further depth of prescribing outside of COEs, where large majority of patient population exists
Foundation of real-world experience across HCPs and families to drive adoption
• Real-world benefits serve as examples of clinical success on DAYBUE treatment
• Sharing successful GI management strategies broadly
- Time to benefit is a key consideration
Persistency continues to track 10 percentage points above clinical trial experience month over month
- 9-monthpersistency rate in real world vs. 9-month persistency in LILAC placebo rollover patients (58% vs. 47%)1
1Real-world persistency measures calculated excluding confirmed discontinuations and patients who have gone >60-days since last refill, compared with observation in placebo rollover patients from the LILAC-1 open label extension study. | 9 |
Expanding DAYBUE Internationally
Pediatric investigation plan (PIP) filed with and accepted by EMA in
Europe
- Filing anticipated in 1Q25
Header text here
Formal meeting with Japanese regulatory agency (PMDA) scheduled
in 2Q24 to discuss clinical plan
NDS in Canada accepted for filing and priority review granted; potential approval around YE24
EMA: European Medical Authority; PMDA: Pharmaceuticals and Medical Devices Agency | 10 |
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ACADIA Pharmaceuticals Inc. published this content on 08 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 May 2024 21:06:27 UTC.