Supernus Pharmaceuticals (SUPN) Annual Novel Mechanisms in Neuropsychiatry Summit 2024 summary

Pipeline updates and clinical trial progress

• SPN-820 is advancing in both MDD and TRD, with open-label and placebo-controlled phase II studies expected to yield data by year-end and early next year, respectively.

• The MDD open-label trial focuses on rapid onset of efficacy, using a single 2,400 mg dose and multiple time-point assessments.

• The TRD phase II-b study uses flexible dosing (800–1,600 mg) and targets 200 completers, with enrollment expected to finish by year-end.

• SPN-817 interim data in treatment-resistant seizures showed efficacy but highlighted tolerability issues, especially GI side effects; mitigation strategies are being tested for phase II-b.

• Full data from the SPN-817 open-label trial and updates on mitigation strategies are expected by year-end.

ADHD market trends and Qelbree launch

• The ADHD market rebounded in 2024 with 9% growth year-to-date, after a slowdown in 2023 due to stimulant shortages.

• Qelbree prescriptions increased 7% in July and 6% in August, indicating strong back-to-school momentum.

• Sales and marketing efforts shift seasonally between adult and pediatric segments to maximize impact.

• Gross-to-net adjustments for Qelbree were lowered to 45%-50% for the year, reflecting lower return rates and ongoing launch dynamics.

• Qelbree is positioned as a differentiated non-stimulant with rapid onset, aiming for greater market penetration in both adults and children.

Financial outlook and strategic priorities

• Gross-to-net is expected to improve through the year, with Q1 typically being the lowest due to co-pay adjustments.

• Qelbree is projected as a multi-hundred million dollar product, with potential to reach $1 billion in peak sales if market share and pricing targets are met.

• Continued investment in promotion and education is seen as key to shifting prescriber habits and increasing adoption.

• Additional pipeline catalysts include SPN-830, with a PDUFA date in February, and ongoing updates for SPN-817 and SPN-820.