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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

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