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. We also continue to make important progress across our pipeline, led by remlifanserin in Alzheimer's disease psychosis. 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. 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. The underlying business remains strong, supported by continued demand growth, disciplined execution, and impact from our expanded field force.
Looking ahead, our most important near-term pipeline milestone is the upcoming phase II readout for remlifanserin in Alzheimer's disease psychosis. 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. 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.
| Metric | Period | Current guidance |
|---|---|---|
| Total revenue | FY2026 | $1.24B-$1.30B (raised) |
| DAYBUE net sales | FY2026 | $480M-$510M (raised; includes initial EU commercial sales in Q4); gross-to-net 23%-25% |
| NUPLAZID net sales | FY2026 | $760M-$790M (unchanged) |
| R&D expense | FY2026 | $355M-$380M (lowered; BD milestone shifted to 2027 plus portfolio prioritization) |
| Remlifanserin ADP Phase II (RADIANT) readout | 2026 | September-October 2026 (tightened) |
| DAYBUE / NUPLAZID long-term | 2028 | Reaffirmed ~$700M DAYBUE and ~$1B NUPLAZID (~$1.7B combined commercial peak) |
| Metric | YoY | Note |
|---|---|---|
| Total revenue | +17% (adjusted) to $308M | Strong execution across DAYBUE and NUPLAZID. |
| DAYBUE net sales | +30% to $125M (27% volume) | Rapid DAYBUE STIX adoption (~40% of U.S. patients) and record returning patients; gross-to-net 24.4%. |
| NUPLAZID net sales | +10% to $183M (8% volume) | New patient prescriptions +20% YoY (highest since Q1 2018) as the expanded field force ramped; gross-to-net 23.9%. |
| R&D expense | $82M vs $78M | Continued pipeline advancement. |
| SG&A expense | $160M vs $134M | NUPLAZID and DAYBUE field-force expansions and increased marketing. |
| Cash and investments | $956M | Strong operating cash generation, providing flexibility for pipeline and business development. |
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| DAYBUE STIX momentum | COE-focused Q1 launch | Broad rollout drove ~40% of U.S. DAYBUE patients onto STIX by quarter-end; by June ~60% of all referrals were STIX, with a diverse mix of naive, returning and switching patients, supporting raised DAYBUE guidance. | — |
| Trofinetide EU approval path | Negative CHMP trend vote, reexamination underway | Positive CHMP opinion secured on reexamination; EC decision expected later in Q3; Germany launch planned early Q4 with Austria/Nordics to follow and initial EU commercial sales now in guidance. | — |
| Remlifanserin ADP program | Enrollment ongoing; readout Aug-Oct | Phase II (RADIANT) enrollment complete at 363 patients, FDA Fast Track granted, readout tightened to September-October; two Phase III studies (30 mg and 60 mg arms) now open for enrollment under the operationally seamless design; ~$4 billion peak potential split roughly 60% ADP / 40% LBDP. | — |
| R&D spend discipline | $385M-$410M guidance | Lowered to $355M-$380M as an ACP-711 BD milestone shifted to 2027 (added higher-dose Phase I exploration) and selected portfolio-prioritization decisions were made. | — |