Harmony Reiterates $1.0 Billion WAKIX Guidance

The Tip Desk · November 4, 2026 · 3 min read

WAKIX net revenue reached $268.9 million in the third quarter, up 12% from a year earlier, as the company kept its full-year target of $1.0 billion to $1.04 billion.

Harmony Biosciences Holdings (HRMY) reported WAKIX net revenue of $268.9 million for the quarter ended September 30, 2026, a 12% increase from $239.5 million a year earlier, and said it remains on track to achieve full-year WAKIX net revenue of $1.0 billion to $1.04 billion.

The sequential step-up from $261.3 million in the second quarter followed a 21% second-quarter increase over the first quarter. The company said the third-quarter result reflected continued demand in a narcolepsy market of about 80,000 diagnosed patients in the United States, commercial execution across the franchise, and the product’s clinical utility.

Estimated average patients grew by 400 to 9,350 in the third quarter, after a 450-patient increase to 8,950 in the second quarter. Harmony said five of the last six quarters achieved more than 400 patient additions. It described WAKIX as the only non-scheduled treatment for excessive daytime sleepiness and cataplexy in adult and pediatric patients with narcolepsy types 1 and 2, with coverage for more than 80% of covered lives. The company also said it had completed expansion of field sales, remote sales, field reimbursement and patient outreach teams in the second quarter.

Net income fell to $48.2 million, or $0.81 a share, from $50.9 million, or $0.87 a share, a year earlier. Harmony said the decline was driven primarily by higher milestone charges and new MSN royalty charges. Operating income was $54.2 million, down from $65.5 million.

Cost of product sold was $80.7 million, or 30% of WAKIX net revenue, versus $59.7 million, or 25%, a year earlier. The company attributed the higher percentage primarily to new royalties related to the Novitium license. Research and development expense was $71.7 million, including a $25.0 million MSN license milestone charge, partly offset by a $15.0 million ZYN002 clinical milestone in the year-ago period. Sales and marketing expense rose 18% to $34.7 million, primarily from expansion of field-based teams. General and administrative expense fell 7% to $27.7 million, primarily from lower stock-based compensation. Total operating expenses were $134.0 million.

Cash, cash equivalents and investments were $1,051.6 million as of September 30, 2026, compared with $882.5 million as of December 31, 2025.

Harmony also reported preliminary multiple-ascending dose data for BP-205, an investigational orexin-2 receptor agonist developed in partnership with Bioprojet. After 14 days of once-daily dosing at 0.1, 0.6, 1 and 3 mg in 94 healthy volunteers, the company said the drug was rapidly absorbed, with a mean Tmax of about 60 minutes, and had a mean effective half-life of about 29 hours with no clinically meaningful change versus the single-ascending dose study. Headache occurred in about 25% of participants. Insomnia was reported in fewer than 20% at all doses; urinary frequency and urgency in fewer than 20% at 1 mg and 3 mg only. No liver or visual adverse events, no clinically significant cardiovascular events or EKG abnormalities, and no serious or severe adverse events were reported.

The company said it remains on track to report Phase 1b data in sleep-deprived healthy volunteers in the first quarter of 2027 and expects to initiate Phase 2 studies across multiple CNS indications by mid-2027. Pitolisant GR’s NDA is under FDA review with a PDUFA date of April 1, 2027. Pitolisant HD Phase 3 topline data are expected in 2027, with a target PDUFA date in 2028.

Peter Anastasiou, Senior Executive Vice President and Chief Operating Officer, will become President and Chief Executive Officer effective January 1, 2027, succeeding Jeffrey Dayno, who will retire on December 31, 2026. Harmony said the transition does not change previously communicated strategic priorities or the expected timing of key commercial and pipeline milestones.