Acadia Pharmaceuticals Inc. 2026 Q2 Earnings Call

Please go ahead. Good afternoon, and thank you for joining us on today's call to discuss ACADIA's second quarter 2026 financial results.

Joining me on the call today from ACADIA are Catherine Owen Adams, our Chief Executive Officer, who will provide some opening remarks, followed by Thomas Garner, our Chief Commercial Officer, who will discuss our commercial brands, DAYBUE and NUPLAZID. Also joining us today is Elizabeth Thompson, PhD, Executive Vice President, Head of Research and Development, who will provide an update on our pipeline programs, and Mark Schneyer, our Chief Financial Officer, who will review the financial highlights. Catherine will then provide some closing remarks before we open up the call for your questions. We are using supplemental slides, which are available on our website in the Events and Presentations section. On today's call, both GAAP and non-GAAP financial measures will be discussed, including non-GAAP NUPLAZID net sales and non-GAAP total revenues.

Non-GAAP financial measures that are also referred to as adjusted financial measures pertain only to NUPLAZID sales in 2025 and their impact on total revenues. All references to non-GAAP are reconciled with the most directly comparable GAAP financial measures in our earnings press release and slide presentation, which has been posted on the investor page of the company's website. Before proceeding, I'd like to remind you that during our call today, we will be making several forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, including goals, expectations, plans, prospects, growth potential, timing of events, future results, and financial guidance, are based on current information, assumptions, and expectations that are inherently subject to change and involve several risks and uncertainties that may cause results to differ materially.

These factors and other risks associated with our business can be found in our filings made with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of today's date, we assume no obligation to update or revise these forward-looking statements as circumstances change, except as required by law. I'll now turn the call over to Catherine for opening remarks.

Thank you, Al. Good afternoon, everyone, and thank you for joining us today. I am pleased to report that ACADIA delivered an outstanding second quarter, demonstrating strong commercial execution across both DAYBUE and NUPLAZID. We also continue to make important progress across our pipeline, led by remlifanserin in Alzheimer's disease psychosis. Let me start with our financial performance. We achieved total revenues of $308 million in the second quarter, representing 17% year-over-year growth on an adjusted basis. This performance reflects strong execution and continued demand for DAYBUE and NUPLAZID. Turning to DAYBUE, the brand delivered net sales of $125 million in the second quarter, representing 30% year-over-year growth. This strong performance was driven by meaningful uptake of DAYBUE STIX, our recently launched powder for oral solution, which is resonating with patients and caregivers in the U.S.

The strong early adoption of DAYBUE STIX reinforces our confidence in this differentiated delivery option and supports the brand's continued growth trajectory. Based on these strong results, we are raising our 2026 guidance range for DAYBUE to $480 million-$510 million. I am also delighted that we recently received a positive opinion from the CHMP following a reexamination process. This outcome represents a significant win for patients with Rett syndrome across Europe and reaffirms the value of DAYBUE as a foundational therapy. We are grateful to the CHMP for its thorough review and pleased to be moving closer to the opportunity to bring this therapy to patients in Europe. This positive opinion, along with strong DAYBUE STIX performance, reinforces our confidence to achieve our ambition of $700 million in DAYBUE sales in 2028.

For NUPLAZID, the brand delivered net sales of $183 million in the second quarter, up 10% year-over-year on an adjusted basis. The underlying business remains strong, supported by continued demand growth, disciplined execution, and impact from our expanded field force. We remain confident in our path to deliver approximately $1 billion in NUPLAZID net sales in 2028. Looking ahead, our most important near-term pipeline milestone is the upcoming phase II readout for remlifanserin in Alzheimer's disease psychosis. We now expect to report top-line results from this study in September to October of this year. If successful, remlifanserin has the potential to be transformational for ACADIA, with peak sales potential of estimated $4 billion across Alzheimer's disease psychosis and Lewy body dementia psychosis. With that overview, let me now turn the call over to Tom to provide more detail on our commercial performance.

Thank you, Catherine, and good afternoon, everyone. I am excited to report another strong quarter for DAYBUE, which generated $125 million in net sales in the second quarter, representing 30% year-over-year growth, driven almost entirely by volume.

Performance was led by continued strength in the U.S. business, with additional contributions from our name patient supply programs. DAYBUE continues to strengthen its position as the foundational standard of care for Rett syndrome, and our second quarter results reflect what we believe to be the growing confidence that physicians, patients, and caregivers have in the therapy. Demand trends accelerated during the quarter as we expanded the launch of DAYBUE STIX beyond Centers of Excellence, which is engaging new patients and bringing previously discontinued patients back to therapy. Importantly, the number of patients returning to DAYBUE reached a record level during the second quarter. Of note, approximately 40% of all U.S. DAYBUE patients were receiving STIX by the end of the quarter. This rapid uptake highlights the significant value STIX is providing to patients and caregivers and reinforces its role as an important growth driver for the DAYBUE franchise.

Turning to DAYBUE outside the United States, we achieved a major regulatory milestone late in the quarter with the receipt of positive CHMP opinion for the treatment of Rett syndrome. We have already begun preparations for commercialization in the European Union following expected approval of DAYBUE by the European Commission. We've assembled a highly experienced team and remain on track to launch in Germany in early Q4. In parallel, we expect to submit pricing and market access submissions in our planned launch markets this year, positioning us for broader expansion across Europe as we work to secure reimbursement approvals. In addition, our name patient supply programs are expected to remain a meaningful contributor to growth through 2026, driven by increasing awareness of DAYBUE globally. Taken together, these trends reinforce our confidence in DAYBUE's increased guidance. With that, let me turn to NUPLAZID.

NUPLAZID delivered another strong quarter, generating $183 million in net sales, representing 10% year-over-year growth on an adjusted basis, driven primarily by volume. We were particularly encouraged by the continued momentum in new patient prescriptions, which have increased 20% year-over-year, representing the highest quarterly volume since the first quarter of 2018. Turning to our expanded field force, execution remains on track, and we are beginning to see the early benefits of that investment emerge, consistent with the six to nine-month ramp period we anticipated. Since expanding the team, we have seen a significant increase in call activity and improved the depth and frequency of engagement with our highest priority customer segments. As a result, we have now reached over 12,000 priority healthcare providers since February, significantly expanding our presence across the clinicians who care for patients living with Parkinson's disease psychosis.

Our direct consumer investments continue to be a meaningful driver of awareness, patient identification, and activation. During Parkinson's Awareness Month in April, our NUPLAZID-branded campaign, Mind Your Mind, and the refreshed More to Parkinson's initiative delivered record audience reach and generated strong engagement across digital and social channels. More importantly, these efforts are translating into action, as reflected in substantial sequential increases in both branded and unbranded patient conversion, reinforcing our ability to connect patients and caregivers with information about Parkinson's disease psychosis and the treatment options available to them. As we pair these awareness-building efforts with our expanded field force, we are increasing both physician and patient recognition of NUPLAZID and further strengthening the foundation for sustainable growth. The leading indicators we're seeing across the market, including growing disease awareness, increased patient engagement, and rising new prescriptions, gives us confidence in the near and long-term trajectory for NUPLAZID.

With that, I'll turn the call over to Liz.