- **Revenue Growth**: U.S. net sales up 6% YoY to $51.8 million, driven by 13% QoQ bottle sales growth.
- **Profitability**: GAAP net income $8.8 million (Q3 2025) vs. $5.9 million (Q2 2025); cash burn reduced to $1.6 million.
- **Pipeline Momentum**: ALISCA-Breast1 trial enrolling 98 patients, with interim data expected Q1 2026.
- **Commercial Strength**: 22% YoY call activity growth, 77% dose escalation adoption, and 25% YoY SD channel demand increase.
- **Strategic Focus**: Maintaining profitability while evaluating Phase III potential for alisertib.

**【Management Opening Remarks】**
- Puma reported Q3 2025 total revenue of $54.5 million, including $51.9 million in product revenue (NERLYNX sales) and $2.6 million in royalty revenue.
- U.S. net sales of NERLYNX increased to $51.8 million (Q3 2025) from $48.8 million (Q3 2024), driven by 13% QoQ growth in ex-factory bottle sales to 2,949 units.
- Inventory build of $3.1 million (vs. $1.3 million Q2 2025 drawdown) impacted net revenue growth.
- Full-year 2025 guidance revised to $198-200 million in net product revenue (up from prior range) and $22-23 million in royalties.

**【CEO & CFO Financial Commentary】**
- GAAP net income: $8.8 million (Q3 2025) vs. $5.9 million (Q2 2025); non-GAAP EPS: $0.21 (Q3 2025) vs. $0.12 (Q2 2025).
- Gross to net adjustment increased to 25.9% (Q3 2025) from 20.8% (Q2 2025) due to Medicare rebate costs.
- R&D expenses rose 20-25% YoY due to faster-than-expected enrollment in alisertib trials.
- Cash burn improved to $1.6 million (Q3 2025) from $2.9 million (Q2 2025), with $94 million in cash as of Q3 end.

**【Commercial Performance】**
- Call activity increased 22% YoY and 17% QoQ, with 65% of sales through specialty pharmacies.
- SD channel demand grew 11% QoQ and 25% YoY, driven by 340B purchasing.
- 77% of patients used dose escalation (up from 71% Q2 2025), supporting adherence.
- Total prescriptions declined 1% QoQ but demand increased 3% QoQ.

**【Clinical Pipeline Update】**
- ALISCA-Breast1 trial enrolling ahead of schedule (98 patients, 14 in screening) with interim analysis expected Q1 2026.
- ALISCA-Lung1 trial increased dose to 60mg BID, with 61 patients enrolled (9 at new dose level).
- Company evaluating potential partnerships to diversify pipeline while maintaining profitability.

**【Q&A Highlights】**
- CEO emphasized commitment to remaining profitable while evaluating alisertib's potential Phase III trials.
- 2025 will mark first year-over-year U.S. demand growth for NERLYNX since 2018.
- Company expects to remain debt-free by mid-2026, enabling cash flow for R&D investments.

Puma Biotechnology, Inc. (PBYI) Q3 2025 Earnings Call Transcript

Revenue

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PBYI

PBYI fundamentals

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