Harmony Biosciences Holdings, Inc. (HRMY) FY2025 10-K Annual Report
Harmony Biosciences Holdings, Inc. (HRMY) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Feb 24, 2026. This page provides AI-powered analysis including business overview, management discussion & analysis (MD&A), risk factors, and key financial data such as revenue, net income, gross margin, operating margin, and return on equity (ROE) extracted from XBRL.
Harmony Biosciences Holdings, Inc. FY2025 10-K Analysis
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
Harmony Biosciences Holdings, Inc. FY2025 Key Financial MetricsXBRL
Revenue
$868M
▲ +21.5% YoY
Net Income
$159M
▲ +9.1% YoY
Gross Margin
77.2%
▼ -90bp YoY
Operating Margin
24.0%
▼ -269bp YoY
Net Margin
18.3%
▼ -208bp YoY
ROE
18.2%
▼ -384bp YoY
Total Assets
$1.3B
▲ +27.3% YoY
EPS (Diluted)
$2.71
▲ +8.0% YoY
Operating Cash Flow
$348M
▲ +58.4% YoY
Source: XBRL data from Harmony Biosciences Holdings, Inc. FY2025 10-K filing on SEC EDGAR. All figures in USD.
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