Harmony Biosciences Q2 2026 earnings: WAKIX revenue rises 30%

Harmony Biosciences (Nasdaq: HRMY) reported Q2 2026 net product revenue of $261.3 million, up 30% from $200.5 million a year earlier, while diluted EPS increased to $1.28 from $0.68. Net income nearly doubled and operating margin expanded, even as new Novitium royalties pushed gross margin lower. WAKIX demand and lower total operating expenses were the main offsets to that product-cost pressure.

Core earnings data

The quarter ended June 30, 2026, was driven by continued WAKIX growth. Profit increased faster than revenue because operating expenses declined, partly reflecting prior-year charges that did not recur in Q2 2026.

Margins and percentage changes marked as approximate are calculated from the reported financial statements.

WAKIX and pipeline performance

WAKIX remained Harmony’s disclosed source of product revenue. The estimated average number of patients increased by 450 to approximately 8,950 during the quarter. Harmony attributed the commercial performance to sustained demand and execution, including the full deployment of expanded field sales, reimbursement and patient outreach teams. It also launched an online portal and revised reimbursement support processes.

Several pipeline and lifecycle-management programs now have milestones concentrated in 2026 and 2027:

• BP-205: Phase 1 single-ascending-dose results showed a time to maximum plasma concentration of 30 to 75 minutes and an average half-life of approximately 25 hours, which the company said could support rapid onset and once-daily dosing. There were no serious or severe treatment-emergent adverse events. Multiple-ascending-dose data are expected in Q4 2026, followed by Phase 1b data in early 2027 and the planned start of Phase 2 studies in mid-2027.
• Pitolisant GR: The FDA accepted the new drug application in July 2026 and set a target PDUFA date of April 1, 2027. Harmony is targeting a launch in the first half of 2027.
• Pitolisant HD: Phase 3 trials in narcolepsy and idiopathic hypersomnia remain underway, with topline results expected in 2027 and a targeted PDUFA date in 2028.
• Other programs: Topline data from the WAKIX TEMPO study in Prader-Willi syndrome are expected in mid-2027. EPX-100 Phase 3 data in rare epilepsies are expected in the first half of 2027.

Royalty costs narrowed gross margin, but operating leverage lifted profit

Cost of product sold rose 66% to $63.2 million, substantially faster than revenue, and increased to 24.2% of revenue from 19.0%. Management attributed the higher cost ratio primarily to new royalties associated with the Novitium license agreement. As a result, gross margin narrowed despite the increase in gross profit dollars.

Below the gross-profit line, expenses moved in Harmony’s favor overall. R&D expense declined 7% to $46.6 million because Q2 2025 included a $15.0 million upfront payment related to the CiRC agreement. G&A expense fell 17% to $28.1 million, primarily because the prior-year quarter included an ANDA settlement charge. Sales and marketing expense increased 13% to $34.1 million due to the expanded field teams, but total operating expenses still declined 5%.

Cash, cash equivalents and investments totaled $962.5 million at June 30, up from $882.5 million at the end of 2025. The asset mix shifted toward investments: cash and equivalents fell to $549.8 million, while short- and long-term investments increased to approximately $412.7 million. Current and long-term debt totaled about $154.0 million.

2026 guidance

Harmony reiterated its full-year WAKIX net revenue guidance without changing the range. First-half 2026 net product revenue was $476.7 million, representing approximately 46% to 48% of the full-year range.

Recent insider transactions

The supplied insider summary records zero purchases and zero sales during the most recent six-month period, with total insider holdings of approximately 6.77 million shares. The two-year history contains four recent entries with a clearly identified action, price and reported value; two newer records lacked a transaction type and value and are therefore excluded.

These disclosures describe the transactions but do not establish the insiders’ reasons for them.

Risks investors should watch

• Dependence on WAKIX: Harmony’s reported product revenue remains concentrated in WAKIX, making patient growth, reimbursement access and commercial execution central to its financial results.
• Continuing gross-margin pressure: New Novitium royalties increased product costs faster than revenue in Q2. Further WAKIX growth may not translate proportionally into gross profit if the higher cost ratio persists.
• Patent and generic competition: Harmony reports WAKIX exclusivity through March 2030, including anticipated pediatric exclusivity, and has settled with six of seven ANDA filers. Litigation involving AET remains ongoing, with closing arguments scheduled for October 22, 2026.
• Clinical and regulatory execution: BP-205 remains in early clinical development, while pitolisant GR, pitolisant HD, TEMPO and EPX-100 depend on future trial results and regulatory decisions. Delays would affect the company’s planned 2027 and 2028 milestones.

Summary

Harmony’s Q2 2026 results combined 30% WAKIX revenue growth with substantial operating leverage, allowing earnings to rise despite royalty-related gross-margin compression. The main issues to monitor are continued WAKIX patient growth, the durability of the higher product-cost ratio, the pitolisant franchise’s patent position and execution across a pipeline with several important 2027 milestones.