third quarter 2026
Filed Nov 5, 2026Puma Biotechnology Reports Third Quarter 2026 Financial Results - Third quarter U.S. NERLYNX sales driven by increased year-over-year demand - Raising 2026 net income guidance
Third-quarter total revenue increased to $55.1 million and operating cash flow increased to $14.6 million, while GAAP net income, non-GAAP adjusted net income and income from operations were lower than the prior-year quarter. The company raised full-year net income guidance to $20–$22 million but narrowed total revenue guidance to $224–$227 million.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Total revenue, third quarter 2026GAAP | $55.1M | – | – |
| Product revenue, net, third quarter 2026GAAP | $54.1M | – | – |
| Royalty revenue, third quarter 2026GAAP | $1M | – | – |
| Total operating costs and expenses, third quarter 2026GAAP | $49.8M | – | – |
| Cost of sales, third quarter 2026GAAP | $15.2M | – | – |
| Selling, general and administrative expenses, third quarter 2026GAAP | $16.3M | – | – |
| Research and development expenses, third quarter 2026GAAP | $18.3M | – | – |
| Income from operations, third quarter 2026GAAP | $5.3M | – | – |
| Interest income, third quarter 2026GAAP | $900K | – | – |
| Interest expense, third quarter 2026GAAP | — | – | – |
| Other income, third quarter 2026GAAP | — | – | – |
| Total other income (expenses), net, third quarter 2026GAAP | $900K | – | – |
| Net income before income taxes, third quarter 2026GAAP | $6.2M | – | – |
| Income tax expense, third quarter 2026GAAP | $(0.2 million) | – | – |
| Net income, third quarter 2026GAAP | $6M | – | – |
| Net income per share of common stock—basic, third quarter 2026GAAP | $0.12 | – | – |
| Net income per share of common stock—diluted, third quarter 2026GAAP | $0.11 | – | – |
| Non-GAAP adjusted net income, third quarter 2026non-GAAP | $8M | – | – |
| Non-GAAP adjusted basic net income per share, third quarter 2026non-GAAP | $0.15 | – | – |
| Non-GAAP adjusted diluted net income per share, third quarter 2026non-GAAP | $0.15 | – | – |
| Net cash provided by operating activities, third quarter 2026GAAP | $14.6M | – | – |
| Total revenue, first nine months of 2026GAAP | $156.4M | – | – |
| Product revenue, net, first nine months of 2026GAAP | $149.6M | – | – |
| Royalty revenue, first nine months of 2026GAAP | $6.8M | – | – |
| Total operating costs and expenses, first nine months of 2026GAAP | $147.4M | – | – |
| Cost of sales, first nine months of 2026GAAP | $38.1M | – | – |
| Selling, general and administrative expenses, first nine months of 2026GAAP | $52.3M | – | – |
| Research and development expenses, first nine months of 2026GAAP | $57M | – | $11.8 million year-over-year increase |
| Income from operations, first nine months of 2026GAAP | $9M | – | – |
| Total other income (expenses), net, first nine months of 2026GAAP | $2M | – | $3.5 million year-over-year increase in other income |
| Net income, first nine months of 2026GAAP | $10.4M | – | – |
| Net income per share of common stock—basic, first nine months of 2026GAAP | $0.20 | – | – |
| Net income per share of common stock—diluted, first nine months of 2026GAAP | $0.20 | – | – |
| Non-GAAP adjusted net income, first nine months of 2026non-GAAP | $16.3M | – | – |
| Non-GAAP adjusted basic net income per share, first nine months of 2026non-GAAP | $0.32 | – | – |
| Non-GAAP adjusted diluted net income per share, first nine months of 2026non-GAAP | $0.31 | – | – |
| Net cash provided by operating activities, first nine months of 2026GAAP | $31.6M | – | – |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| Product revenue, netProduct revenue, net consists entirely of revenue from sales of NERLYNX. | $54.1M | – | – |
| Royalty revenueThe third quarter of 2026 included a $2.1 million reduction to royalty revenue as a change in accounting estimate, reflecting new third-party market data confirming that the market share of generic versions of NERLYNX in China reached a specified threshold during the period. | $1M | – | – |
Fourth Quarter and Full Year 2026 outlook
- RevenueFourth Quarter 2026 Total Revenue $67–$70 million; New Full Year 2026 Total Revenue $224–$227 million
- NoteFourth Quarter 2026 Net Product Revenue $56–$58 million
- NoteNew Full Year 2026 Net Product Revenue $206–$208 million
- NoteFourth Quarter 2026 Royalty Revenue $11–$12 million
- NoteNew Full Year 2026 Royalty Revenue $18–$19 million
- NoteFourth Quarter 2026 Net Income $10–$12 million
- NoteNew Full Year 2026 Net Income $20–$22 million
- NoteFourth Quarter 2026 Gross to Net Adjustment 28%–29%
- NoteNew Full Year 2026 Gross to Net Adjustment 27.5%–28%
- NoteThe outlook above does not include any potential adjustments for tax valuation allowance.
What drove it
- Third quarter U.S. NERLYNX sales were positively impacted by increased year-over-year demand.
- Third quarter U.S. NERLYNX sales were negatively impacted by higher than expected gross to net due to an increase in Medicaid and 340B sales.
- Sales to Puma’s ex-U.S. commercial partners were delayed from the third quarter to the fourth quarter.
- Third-quarter and first-nine-month cost of sales increases were due primarily to higher product sales to an international partner.
- The first-nine-month R&D increase resulted primarily from an $8.9 million increase in clinical trial expense reflecting increased alisertib study activity, and an increase of approximately $2.9 million in internal R&D expense primarily due to increased employee compensation including the hiring of a new executive.
- The first-nine-month increase in other income resulted primarily from a decrease in interest expense reflecting a lower debt balance, as Puma paid down its debt principal in May 2026.
Concerns
- Royalty revenue was $1.0 million in the third quarter of 2026 versus $2.6 million in the third quarter of 2025.
- The third quarter and first nine months of 2026 included a $2.1 million reduction to royalty revenue as a change in accounting estimate related to generic versions of NERLYNX in China.
- GAAP net income was $6.0 million in the third quarter of 2026 compared to $8.8 million in the third quarter of 2025.
- R&D expenses were $18.3 million in the third quarter of 2026 compared to $15.9 million in the third quarter of 2025.
- Fourth-quarter gross to net adjustment guidance is 28%–29%.
What to watch
- Presentation of updated data from ALISCA-Breast1 at the San Antonio Breast Cancer Symposium in December 2026.
- Continued enrollment in ALISCA-Breast1 during H2 2026.
- Continued enrollment of ALISCA-Lung1 and ALISCA-Lung2 in Q4 2026.
- Initiation of discussions with global regulatory agencies regarding the Phase III trial design for alisertib in H1 2027.
- Presentation of updated data from ALISCA-Lung1 in 2027.
- Fourth-quarter 2026 net product revenue guidance of $56–$58 million and royalty revenue guidance of $11–$12 million.
Balance sheet and cash flow
- Cash and cash equivalents were $41.5 million at September 30, 2026, compared to $29.6 million at December 31, 2025.
- Marketable securities were $67.0 million at September 30, 2026, compared to $67.9 million at December 31, 2025.
- Cash, cash equivalents and marketable securities were $108.5 million at September 30, 2026, compared to $97.5 million at December 31, 2025.
- Working capital was $105.7 million at September 30, 2026, compared to $81.4 million at December 31, 2025.
- Current portion of long-term debt was — at September 30, 2026, compared to $22.5 million at December 31, 2025.
- Stockholders’ equity was $146.6 million at September 30, 2026, compared to $130.3 million at December 31, 2025.
- Net cash provided by operating activities for the first nine months of 2026 was $31.6 million, compared to $27.4 million in the first nine months of 2025.
- Cash provided by investing activities for the first nine months of 2026 was $0.7 million, compared to cash used in investing activities of $(9.2 million) in the first nine months of 2025.
- Cash used in financing activities for the first nine months of 2026 was $(22.5 million), compared to $(33.9 million) in the first nine months of 2025.
- Net increase in cash, cash equivalents, and restricted cash for the first nine months of 2026 was $9.8 million, compared to a net decrease of $(15.7 million) in the first nine months of 2025.
Analysis
Puma reported third-quarter 2026 total revenue of $55.1 million, compared with $54.5 million in the third quarter of 2025. Net product revenue was $54.1 million versus $51.9 million, and management said third-quarter U.S. NERLYNX sales benefited from increased year-over-year demand. Royalty revenue was $1.0 million versus $2.6 million. The company said the third quarter and first nine months included a $2.1 million reduction to royalty revenue as a change in accounting estimate tied to generic NERLYNX market share in China.
Profitability declined despite the increase in total revenue. Income from operations was $5.3 million, compared with $9.6 million, while GAAP net income was $6.0 million, or $0.11 per diluted share, compared with $8.8 million, or $0.17 per diluted share. Non-GAAP adjusted net income was $8.0 million, or $0.15 per diluted share, compared with $10.5 million, or $0.21 per diluted share. Total operating costs and expenses increased to $49.8 million from $44.9 million, with cost of sales at $15.2 million and R&D expense at $18.3 million.
For the first nine months, total revenue was $156.4 million compared with $152.9 million, but GAAP net income was $10.4 million compared with $17.7 million. R&D expense increased to $57.0 million from $45.2 million. Puma attributed the $11.8 million year-over-year R&D increase primarily to an $8.9 million increase in clinical trial expense reflecting increased alisertib study activity, along with approximately $2.9 million of higher internal R&D expense. Operating cash flow was $14.6 million for the third quarter and $31.6 million for the first nine months, compared with $9.7 million and $27.4 million, respectively.
Liquidity included $108.5 million of cash, cash equivalents and marketable securities at September 30, 2026, compared with $97.5 million at December 31, 2025. The current portion of long-term debt was — at September 30, 2026, compared with $22.5 million at December 31, 2025. Management attributed the first-nine-month improvement in other income partly to lower interest expense after paying down debt principal in May 2026.
For the fourth quarter, Puma guided net product revenue to $56–$58 million, royalty revenue to $11–$12 million, total revenue to $67–$70 million and net income to $10–$12 million. New full-year guidance calls for net product revenue of $206–$208 million, royalty revenue of $18–$19 million, total revenue of $224–$227 million and net income of $20–$22 million. The full-year net income range is above the $17–$20 million prior range shown in the release, while the total revenue range is narrower than the $224–$231 million prior range shown in the release. Gross to net adjustment guidance is 28%–29% for the fourth quarter and 27.5%–28% for the full year.
Management, verbatim
Third quarter U.S. NERLYNX sales were positively impacted by increased year-over-year demand and were negatively impacted by higher than expected gross to net due to an increase in Medicaid and 340B sales, as well as a delay in sales to Puma’s ex-U.S. commercial partners that shifted from the third quarter to the fourth quarter.
Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma
We continue to anticipate increased year-over-year demand for NERLYNX, while we continue to advance alisertib across our ALISCA® clinical development programs.
Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma
Not in the filing
stated, not guessed- Gross margin was not reported.
- Free cash flow was not reported.
- Share repurchases and dividends were not reported.
- Total long-term debt was not reported.
- Quarter-over-quarter comparisons were not reported.
- A previous earnings release outlook section was not provided, so no formal actual-versus-prior-guidance comparison is included.
- Guidance for gross margin, operating expenses and tax rate was not reported.
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was checked against the filing text, and a metric whose value, prior period and change do not add up is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.