ACADIA (ACAD) Q2 FY26 earnings call: guidance and Q&A

What effect size on SAPS-H+D is considered Phase III enabling, and what other factors are being considered for success?

The Phase II study is 80% powered for a 0.4 effect size on SAPS-H+D, which is considered a moderate effect. While there's some flexibility, a lower level might raise concerns about replication. Beyond SAPS-H+D, the company will look at responder analyses, safety profile (avoiding negative cognitive/motor impact), and overall meaningfulness for patients, including ease of use.

“There is a lower level beyond which you start worrying about whether you'd be able to replicate the effect. But I think we've got a ways there.”

asked by Tess Romero (JPMorgan) · answered by Elizabeth Thompson

How does the 0.4 effect size target compare to pimavanserin's 0.32 in Study 19, given different scales? Also, why are Phase III studies enrolling before Phase II data, and which dose is being used?

The 0.4 effect size for remlifanserin is considered defensible due to using a more sensitive endpoint (SAPS-H+D) and enriching for a more severe psychosis population, which showed a higher effect size (0.6) in Study 19. The Phase III studies are operationally seamless, allowing enrollment to begin after Phase II completion. Both 30mg and 60mg dosing arms are currently enrolling, with flexibility to modify based on Phase II data.

“if you look at the more severe psychosis population, your effect size goes up to more like 0.6. So we think that 0.4 is a defensible and appropriate powering assumption.”

asked by Ashwani Verma (UBS) · answered by Elizabeth Thompson

Can you quantify the European opportunity for DAYBUE, specify launch countries beyond Germany, and describe the expected ramp?

The company estimates less than 15% of the $700 million DAYBUE sales target for 2028 will come from Europe. Germany will be the initial launch market in early Q4, followed by other early launch markets like Nordics and Austria. The ramp will be gradual, with patients currently receiving free drug in Germany transitioning to paid treatment, and broader expansion as reimbursement approvals are secured. Named patient supply programs will continue to contribute.

“as you look at the $700 million guidance for 2028, we estimate somewhere less than 15% of that number to come from Europe.”

asked by Marc Goodman (Leerink Partners) · answered by Thomas Garner

Do you expect the discontinuation rate to change with STIX? What percentage discount is expected for DAYBUE pricing in major European countries?

STIX performance on tolerability and discontinuation rates appears similar to the oral solution historically, but it's re-engaging previously discontinued patients. Overall discontinuation rates remain under double digits and consistent. For Europe pricing, the company is not guiding on discounts yet, as negotiations with national reimbursement authorities will follow Germany's initial 6-month free pricing period, with first discussions expected mid-next year.

“Overall, as you think about discontinuation rates... they remain under double digits, it remains very, very consistent.”

asked by Tazeen Ahmad (Bank of America) · answered by Thomas Garner

Can you discuss STIX patient trends in July/August and the market dynamic for Rett syndrome with potential gene therapies?

Momentum for STIX from Q2 is expected to continue into Q3, with early signs indicating this. For gene therapies, ACADIA does not foresee any impact on its commercial forecast for DAYBUE, believing it will remain the standard of care. DAYBUE can be used pre or post gene therapy, offers inherent flexibility, is reversible, and its profile is well-known, making it an important treatment even with new options.

“we don't see any impact to our commercial forecast either in the short or long term with the potential introduction of a gene therapy”

asked by Guofang Li (Wolfe Research) · answered by Catherine Owen Adams

Is the 15% contribution to 2028 sales a reasonable benchmark for DAYBUE's ex-US peak opportunity? How does remlifanserin's improved molecule relate to receptor occupancy and expected efficacy compared to pimavanserin?

The $700 million DAYBUE sales target for 2028 is not the peak opportunity, and the 15% ex-US contribution is an average analog for rare diseases, subject to reimbursement decisions. For remlifanserin, while pimavanserin achieves high receptor occupancy in healthy volunteers, higher levels are believed necessary in elderly/diseased patients. Exposure-response analyses suggest higher levels than pimavanserin's marketed dose are associated with greater efficacy, supporting potential for improved efficacy with remlifanserin.

“exposure response analyses that we've done out of prior data sets in both Alzheimer's and Lewy body that do suggest that levels that are higher than what you can get to with the marketed dose of pimavanserin on average do seem to be associated with higher efficacy.”

asked by Julian Hung (Stifel) · answered by Elizabeth Thompson