Harmony Biosciences Q3 WAKIX Revenue Rises 12%

Harmony Biosciences (NASDAQ: HRMY) reported a 12% increase in third-quarter net product revenue as demand for narcolepsy treatment WAKIX continued to expand, while higher research, commercial and royalty-related costs weighed on quarterly profit. The company reiterated its 2026 WAKIX net revenue guidance of $1.00 billion to $1.04 billion and said it remains on track to surpass $1 billion for the full year.

Net product revenue reached $268.9 million for the three months ended September 30, up from $239.5 million a year earlier. Harmony recorded about 9,350 average patients on WAKIX during the quarter, with 400 net patient additions. The company has added more than 400 net patients in five of the past six quarters.

Third-quarter net income declined 5% to $48.2 million from $50.9 million, while diluted earnings per share fell to $0.81 from $0.87. For the first nine months of 2026, net product revenue rose 19% to $745.6 million and net income increased 15% to $156.1 million. Nine-month diluted earnings per share was $2.63, compared with $2.32 in the prior-year period.

Higher investment and royalty costs

Cost of product sold increased 35% to $80.7 million in the quarter, primarily because of new royalties associated with the Novitium license agreement signed in the first quarter of 2026. Total operating expenses rose 17% to $134.0 million.

Research and development expense increased 30% to $71.7 million, largely reflecting a $25.0 million charge tied to an MSN license milestone. The comparison was partly offset by a $15.0 million ZYN002 milestone charge recorded in the prior-year quarter. Sales and marketing expense rose 18% to $34.7 million as Harmony expanded its field-based team, while general and administrative expense declined 7% to $27.7 million due primarily to lower stock-based compensation.

Cash, cash equivalents and investments totaled about $1.05 billion at quarter-end, up from $778.4 million a year earlier and $962.5 million at the end of the second quarter. Harmony said it generated $89 million in cash during the quarter and plans to use its balance sheet to support development of BP-205 and pursue business-development transactions. Its acquisition and licensing priorities include assets that could contribute revenue between 2028 and 2032, as well as earlier-stage programs with longer-term potential in sleep disorders, epilepsy and other central nervous system conditions.

BP-205 advances toward Phase 2

Harmony also highlighted preliminary Phase 1 multiple-ascending-dose results for BP-205, an orexin-2 receptor agonist that the company describes as having a potentially best-in-class profile. The randomized study evaluated 14 days of once-daily dosing at levels ranging from 0.1 milligram to 3 milligrams in 94 healthy volunteers.

BP-205 was generally well tolerated across the tested doses, with no serious or severe treatment-emergent adverse events, liver or visual adverse events, clinically significant cardiovascular events or electrocardiogram abnormalities reported. Headache was the most common adverse event, affecting about 25% of participants. Mild insomnia occurred in fewer than 20%, while urinary frequency or urgency was reported in fewer than 20% at the 1-milligram and 3-milligram doses.

The candidate showed rapid absorption and a mean effective half-life of approximately 29 hours after 14 days, which the company said supports once-daily dosing. Phase 1b data from sleep-deprived healthy volunteers are expected in the first quarter of 2027, followed by the planned initiation of Phase 2 studies in multiple CNS indications by mid-2027.

Harmony’s broader pipeline includes five Phase 3 registrational trials across five rare CNS indications. The Food and Drug Administration is reviewing the gastro-resistant formulation of pitolisant, with an April 1, 2027 PDUFA date and a planned launch in the first half of 2027. Phase 3 topline data for high-dose pitolisant in narcolepsy and idiopathic hypersomnia are expected in 2027, while data from the TEMPO study in Prader-Willi syndrome are expected in mid-2027.

Phase 3 trials of EPX-100 in Lennox-Gastaut syndrome and Dravet syndrome are also underway, with topline results expected in mid-2027 and anticipated PDUFA dates in 2028.

Patent proceedings remain a key uncertainty

Harmony said its intellectual-property strategy supports WAKIX exclusivity through March 2030, including pediatric exclusivity, and noted that it has reached settlements with six of seven abbreviated new drug application filers. Litigation involving pitolisant polymorph and method-of-use patents remains active, with a ruling expected around the end of the 30-month stay in February 2027.

Harmony and Novitium are also pursuing a separate infringement case involving an amorphous pitolisant patent licensed to Harmony that runs through 2042. A preliminary injunction hearing is scheduled for January 26, 2027, with a ruling expected by February 14. The company cautioned that outcomes may also depend on regulatory approvals, clinical-trial results, market acceptance, reimbursement, competition, commercialization execution and its ability to protect the pitolisant franchise.