Vanda Pharmaceuticals (VNDA) Q3 2026 earnings summary

Executive summary

• Q3 2026 net product sales rose 24% YoY to $69.8M, led by Fanapt growth and HETLIOZ shipment timing; operating expenses fell 18% QoQ to $93.3M.

• NEREUS launched in the U.S.; BYSANTI is expected to launch in Q4 2026, while Quimilza’s BLA is under FDA review.

Financial highlights

• Q3 revenue was $69.8M vs. $56.3M a year earlier; operating loss was $23.5M vs. $31.3M, and net loss was $22.6M in both periods.

• Q3 operating expenses were $93.3M, up 7% YoY and down 18% QoQ; 9M expenses were $309.6M vs. $269.7M.

• 9M revenue increased 8% to $172.1M; net loss was $133.6M vs. $79.3M and operating loss was $137.6M vs. $110.8M.

• Q3 R&D rose 22% to $27.6M and SG&A declined 1% to $59.6M; 9M R&D rose 16% to $93.0M and SG&A rose 14% to $199.8M.

Outlook and guidance

• FY 2026 revenue guidance is greater than $240M, with NEREUS revenue expected to be under $10M; operating expenses are expected to decline as Phase III and launch-preparation activities conclude.

• BYSANTI U.S. launch is expected in Q4 2026; Phase III MDD results are expected in H1 2027, with 55% of the 500-patient enrollment target enrolled.

• Quimilza’s GPP BLA is under FDA review, with a December 12, 2026 PDUFA date; commercial product could be ready a few months after a timely FDA decision, with launch targeted for H1 2027.

• 2026 cash burn is expected to exceed 2025; available cash and marketable securities are expected to fund operations for at least 12 months, with significant working capital needs continuing.