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- **Revenue Growth Surpasses Expectations**: Q3 2025 net revenue of $239.5 million (+29% YoY), with 500 new patients quarterly added, raising full-year guidance to $845-$865 million.
- **WAKIX Blockbuster Trajectory**: On track for $1 billion+ annual revenue in narcolepsy by 2026, driven by 8,100 average patients and stable NT1/NT2 split.
- **Pipeline Momentum**: Pitolisant HD Phase III trials on track for Q4 2025 initiation, GR formulation showing 100% tolerability in dosing study.
- **Financial Strength**: $778 million cash balance, non-GAAP EPS of $1.08, and confidence in 5 Phase III programs by year-end.
- **Strategic Focus**: CEO emphasizes CNS innovation and M&A potential, with pipeline investments supporting long-term growth.

**【CEO Summary Section】**
- Reported Q3 2025 net revenue of $239.5 million, up 29% YoY, with 500 average new patients added quarterly, exceeding prior guidance.
- Raised full-year revenue guidance to $845-$865 million, targeting $1 billion+ annual revenue for WAKIX in narcolepsy by 2026.
- Highlighted robust pipeline progress, including IND submission for pitolisant HD and Phase III trials for narcolepsy and idiopathic hypersomnia (IH).

**【CCO Update】**
- WAKIX achieved 8,100 average patients on therapy, with 500 new quarterly adds, driven by improved sales execution, payer coverage, and patient support.
- Emphasized differentiation of WAKIX as the only nonscheduled treatment, with 45% NT1 and 55% NT2 patient split remaining stable.
- Discussed life cycle management strategies for pitolisant GR (fast-to-market, no titration) and HD (enhanced efficacy, fatigue indication).

**【CMO Pipeline Update】**
- Pitolisant HD Phase III trials for narcolepsy and IH on track to initiate Q4 2025, targeting PDUFA dates in 2028.
- Pitolisant GR dosing study showed 100% tolerability at 17.8mg, with 98% tolerating 35.6mg, supporting Q1 2027 BE study readout.
- Orexin-2 agonist (BP1.15205) Phase I study set to begin Q4 2025, leveraging preclinical data showing efficacy at low doses.

**【CFO Financials】**
- Q3 2025 non-GAAP net income of $63.5 million ($1.08 EPS), up 11% YoY, with cash balance of $778 million.
- Raised 2025 revenue guidance to $845-$865 million, driven by WAKIX demand and pipeline investments.
- Projected 5 Phase III programs by year-end, including $4 million milestone for orexin-2 Phase I.

**【Q&A Highlights】**
- **Sustainability of Growth**: CCO cited strong fundamentals, execution, and pipeline confidence for continued patient adds beyond 2026.
- **Orexin Competition**: CCO emphasized WAKIX's position as a polytherapy backbone, with historical resilience to new entrants.
- **Pipeline Strategy**: CEO reaffirmed focus on CNS innovation, with $778M cash balance for strategic M&A and pipeline expansion.
- **Pitolisant HD Feedback**: Early physician and payer interest in HD's differentiated efficacy and no-titration profile.
- **Fragile X Update**: Ongoing data review for ZYN002, with potential implications for 22q deletion syndrome trial reactivation.


Harmony Biosciences Holdings, Inc. (HRMY) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

HRMY

HRMY fundamentals

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