Puma Biotechnology Reports Third Quarter 2026 Financial Results
PUMA BIOTECHNOLOGY, INC. (PBYI) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 News Release Puma 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 LOS ANGELES, Calif., Nov. 5, 2026 - Puma Biotechnology, Inc. (NASDAQ: PBYI), a
How this was made
The 30-second read
Why it matters
The raised net income guidance reflects confidence in upcoming alisertib trial data and continued demand for NERLYNX.
Market read
The earnings release and guidance raise provide a fresh catalyst for PBYI and may influence peer biotech valuations.
What to watch
Higher Medicaid and 340B sales could compress margins, offsetting revenue growth.
Puma 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.
Background
Puma Biotechnology's only commercial product, NERLYNX, showed modest revenue growth YoY, while operating costs rose.
Ticker impact
Puma Biotechnology disclosed Q3 2026 results and raised its 2026 net income guidance.
likely upward pressure as investors price in higher net income expectations
The filing reports higher Q3 revenue and net cash, and explicitly states the company is raising its net income guidance for 2026, which typically supports the stock.
Market effects
Biotech sector may see modest uplift as a peer shows stronger demand for its oncology product.
U.S. biotech investors could adjust exposure to small-cap oncology plays.
Limited to investors tracking U.S. biotech earnings.
Counterpoint
If the raised guidance is already priced in, the stock could face a short‑term pull‑back.
Key entities
- companyPuma Biotechnology, Inc.
Biopharmaceutical company reporting Q3 2026 results.
