Short answer
Harmony Biosciences Holdings, Inc. (HRMY) filed its fiscal 2025 10-K annual report with the SEC on Feb 24, 2026. It reported revenue of $868M (+21.5% year over year) and net income of $159M.
- Top risk flagged: Regulatory risk: FDA post-marketing requirements and commitments for WAKIX, including recent approvals for pediatric narcolepsy in June 2024 and February 2026
FY2025 key financial metrics · XBRL
- Revenue
- $868M
- +21.5% YoY
- Net income
- $159M
- +9.1% YoY
- Operating margin
- 24.0%
- −2.7 pp YoY
- Gross margin
- 77.2%
- −0.9 pp YoY
- EPS (diluted)
- $2.71
- +8.0% YoY
- ROE
- 18.2%
- −3.8 pp YoY
- Operating cash flow
- $348M
- +58.4% YoY
Source: XBRL data from the Harmony Biosciences Holdings, Inc. (HRMY) FY2025 10-K on SEC EDGAR. USD.
Harmony Biosciences Holdings, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Neuroscience-focused biopharma developing innovative treatments for rare neurological diseases emphasizing sleep/wake disorders, rare epilepsy, and neurobehavioral conditions
- New products and expansions: Acquired orexin 2 receptor agonist BP1.15205 (preclinical), launched Phase 3 trials for next-gen pitolisant formulations (GR and HD), expanded rare epilepsy pipeline via Epygenix acquisition with EPX-100 and EPX-200
- Strategic shift: Diversified beyond pitolisant with Zynerba acquisition (ZYN002 cannabidiol gel), entry into orexin science, and cell replacement therapy collaboration with CiRC Biosciences
- Quantitative highlight: WAKIX net revenue $868.5M in 2025 with ~8,500 average patients on therapy; filed NDA for Pitolisant GR targeting Q1 2027 FDA review
- Noteworthy: FDA approvals expanded WAKIX pediatric indications for EDS (2024) and cataplexy (2026); Phase 3 negative RECONNECT trial led to phasing out ZYN002 in Fragile X syndrome
Management Discussion & Analysis
- Revenue $868.5M, up 21.5% YoY (+$153.7M) driven by 18.3% volume growth and 7.0% price increase, offset by 3.6% higher rebates
- Gross margin 77.2% (cost of sales 22.8%) vs 78.1% (cost of sales 21.9%) in prior year, impacted by higher royalty tier
- R&D expenses $189.6M, up 30.0% (+$43.8M) led by EPX-100 (+$27.2M), ZYN002 (+$8.0M), and Pitolisant GR/HD (+$11.9M); offset by $7.7M decrease for Pitolisant IH
- Net income $158.7M, up from $145.5M; Operating income $208.5M vs $190.8M prior year
- Capital allocation: no specific buybacks or dividends disclosed; $0.5M rent/consulting fees; increased investments in clinical trials and manufacturing; forward-looking focus on advancing multiple Phase 3 programs and pursuing pediatric exclusivity with potential PDUFA dates in 2027-2028
Risk Factors
- Regulatory risk: FDA post-marketing requirements and commitments for WAKIX, including recent approvals for pediatric narcolepsy in June 2024 and February 2026
- Geopolitical/macroeconomic risk: reliance on third-party manufacturing with sole-source suppliers and manufacturers, exposing supply chain to disruption risks
- Operational risk: dependence on Bioprojet license for core pitolisant IP, with risk of termination restricting commercialization rights in the U.S.
- Competitive risk: WAKIX faces competition from modafinil, which showed non-inferiority, potentially limiting physician prescribing and market acceptance
- Financial risk: dependence on WAKIX sales for substantially all revenue, with failure to grow sales potentially causing loss of profitability and need for additional financing
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