Puma Biotechnology, Inc.: Q1 FY2026 earnings call
What management said about Q1 FY2026, from the documents filed with the SEC on 7 May 2026: press release. Guidance figures: 3 raised, 1 lowered, 5 new, 2 kept. The quarter’s numbers.
Key takeaways
- GAAP net loss in first quarter: The company reported a GAAP net loss of $3.8 million, or $0.07 per share, compared with net income of $3.0 million, or $0.06 per share, a year earlier. Source
- NERLYNX net product revenue slightly lower: NERLYNX net product revenue was $42.0 million, compared with $43.1 million in the first quarter of 2025. NERLYNX is the company's only commercial product. Source
- R&D rose on alisertib trial activity: Research and development expenses were $19.8 million, compared with $13.8 million a year earlier. Clinical trial expense rose about $5.2 million on alisertib study activity. Source
- Full-year product revenue guidance raised: Management said the first quarter marked another year-over-year demand increase, which resulted in raised full-year 2026 revenue guidance. Source
- Full-year net income guidance raised: Full-year net income guidance was raised to $16 - $19 million from $10 - $13 million. The company stated that it does not include potential tax valuation allowance adjustments. Source
- Continuing alisertib development in two trials: Management said it looks forward to continuing development of alisertib in ALISCA-Breast1 and ALISCA-Lung1 while managing resources to achieve positive net income this year. Source
- Debt paid down to zero: Total debt fell to $11.3 million at March 31, 2026, from $22.5 million. The final 2021 Note Purchase Agreement payment on May 4, 2026 reduced debt to zero. Source
“We are very pleased that the first quarter of 2026 marked another quarter of year-over-year demand increase resulting in our raising revenue guidance for 2026.”
Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma
Guidance
| Area | Period | Figure | Against last quarter |
|---|---|---|---|
| Net product revenue Source | Second quarter 2026 | $50 - $52 million | New |
| Royalty revenue Source | Second quarter 2026 | $2 - $3 million | New |
| Total revenue Source | Second quarter 2026 | $52 - $55 million | New |
| Net income Source | Second quarter 2026 | $2 - $4 million | New |
| Gross to net adjustment Source | Second quarter 2026 | 27% - 28% | New |
| Net product revenue Source | Full year 2026 | $202 - 206 million | Raised from $194 - $198 million |
| Royalty revenue Source | Full year 2026 | $20 - $23 million | Kept |
| License revenue Source | Full year 2026 | $0 | Kept |
| Total revenue Source | Full year 2026 | $222 - $229 million | Raised from $214 - $221 million |
| Net income Source | Full year 2026 | $16 - $19 million | Raised from $10 - $13 million |
| Gross to net adjustment Source | Full year 2026 | 26.5% - 27.5% | Lowered from 27.5% - 28.5% |
What changed from last quarter
- Guidance raised: Full-year 2026 net product revenue guidance was raised to $202 - 206 million from $194 - $198 million, which management linked to increased demand. Source
- Guidance raised: Full-year 2026 net income guidance was raised to $16 - $19 million from $10 - $13 million, and total revenue guidance was raised to $222 - $229 million from $214 - $221 million. Source
- Guidance lowered: Full-year gross to net adjustment guidance was lowered to 26.5% - 27.5% from 27.5% - 28.5%. Source
- New guidance: Second-quarter 2026 guidance was given for net product revenue, royalty revenue, total revenue, net income and gross to net adjustment. Source
- New: Enrollment expansion of ALISCA-Breast1 is now listed as a milestone for H2 2026 to obtain more data in biomarker focused populations. Source
- Ended: The 2021 Note Purchase Agreement was paid off on May 4, 2026, reducing debt to zero and ending remaining obligations other than customary indemnification. Source
Results and profitability
- GAAP net loss in first quarter: The company reported a GAAP net loss of $3.8 million, or $0.07 per share, compared with net income of $3.0 million, or $0.06 per share, a year earlier. Source
- Non-GAAP loss excludes stock compensation: Non-GAAP adjusted net loss was $1.9 million, or $0.04 per share, compared with non-GAAP adjusted net income of $5.0 million, or $0.10 per share, in the first quarter of 2025. Source
- Operating costs rose above revenue: Total operating costs and expenses were $48.6 million, compared with $42.0 million a year earlier, against total revenue of $44.8 million. The company reported an operating loss of $3.8 million. Source
- Operating cash flow higher year on year: Net cash provided by operating activities was $15.4 million, compared with $3.6 million in the first quarter of 2025. Source
Product and royalty revenue
- NERLYNX net product revenue slightly lower: NERLYNX net product revenue was $42.0 million, compared with $43.1 million in the first quarter of 2025. NERLYNX is the company's only commercial product. Source
- Royalty revenue near prior-year level: Royalty revenue was $2.8 million, against $2.9 million in the first quarter of 2025, bringing total revenue to $44.8 million. Source
- Product revenue above prior guidance range: The prior release guided first-quarter net product revenue to $36 - $39 million. Reported net product revenue was $42.0 million.
“We are also pleased with the interim data from ALISCA™-Breast1 and ALISCA™-Lung1, which appear to demonstrate an increased clinical effect of alisertib”
Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma
Operating costs and R&D
- R&D rose on alisertib trial activity: Research and development expenses were $19.8 million, compared with $13.8 million a year earlier. Clinical trial expense rose about $5.2 million on alisertib study activity. Source
- SG&A up on pay and marketing: SG&A expenses were $18.4 million, compared with $17.6 million. Employee compensation rose $0.9 million and marketing and market access costs rose $0.4 million. Source
- Stock compensation excluded from non-GAAP: Stock-based compensation of $1.1 million in SG&A and $0.8 million in R&D was excluded from the non-GAAP adjusted net loss. Source
Gross-to-net and cost of sales
- Second-quarter gross-to-net guided: The company guided second-quarter gross to net adjustment to 27% - 28%. Source
- Full-year gross-to-net range lowered: The full-year gross to net adjustment range was lowered to 26.5% - 27.5% from 27.5% - 28.5%. Source
- Cost of sales flat year on year: Cost of sales was $10.4 million, compared with $10.6 million, which management attributed to consistent product bottle sales. Source
“We look forward to continuing the development of alisertib in ALISCA™-Breast1 and ALISCA™-Lung1 while carefully managing our resources to achieve positive net income for this year.”
Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma
Demand and 2026 guidance
- Full-year product revenue guidance raised: Management said the first quarter marked another year-over-year demand increase, which resulted in raised full-year 2026 revenue guidance. Source
- Full-year net income guidance raised: Full-year net income guidance was raised to $16 - $19 million from $10 - $13 million. The company stated that it does not include potential tax valuation allowance adjustments. Source
- Second consecutive year of demand growth: Management said current forecasts show full-year 2026 will be the second consecutive year of NERLYNX demand increase year over year. Source
- Full-year total revenue guidance raised: Full-year total revenue guidance was raised to $222 - $229 million from $214 - $221 million. Source
- Second-quarter guidance given: Second-quarter guidance covers net product revenue of $50 - $52 million, total revenue of $52 - $55 million and net income of $2 - $4 million. Source
Alisertib development
- Continuing alisertib development in two trials: Management said it looks forward to continuing development of alisertib in ALISCA-Breast1 and ALISCA-Lung1 while managing resources to achieve positive net income this year. Source
- Interim data reported for both trials: Management said it was pleased with interim data from ALISCA-Breast1 and ALISCA-Lung1, which appear to show increased clinical effect in biomarker subgroups where aurora kinase A appears to play a role. Source
- ALISCA-Breast1 enrollment expansion planned: Enrollment expansion in ALISCA-Breast1 is planned for H2 2026 to obtain more data in biomarker focused populations. Source
- ALISCA-Lung1 expansion planned: Expansion of ALISCA-Lung1, a Phase II monotherapy trial in extensive stage small cell lung cancer, is planned for H2 2026. Source
- Updated Breast1 data due Q4 2026: Management said updated data from ALISCA-Breast1 is expected in Q4 2026. Source
Cash, debt and capital
- Cash and securities rose in quarter: Cash, cash equivalents and marketable securities were $101.5 million at March 31, 2026, compared with $97.5 million at December 31, 2025. Source
- Debt paid down to zero: Total debt fell to $11.3 million at March 31, 2026, from $22.5 million. The final 2021 Note Purchase Agreement payment on May 4, 2026 reduced debt to zero. Source
- Financing outflows unchanged year on year: Net cash used in financing activities was $11.3 million in both the first quarter of 2026 and the first quarter of 2025. Source
Coming up, as management said on 7 May 2026
- ALISCA-Breast1 enrollment expansion: Management said enrollment in ALISCA-Breast1 will be expanded in H2 2026 to obtain more data in biomarker focused populations. Source
- ALISCA-Lung1 expansion: Management said ALISCA-Lung1 will be expanded in H2 2026. Source
- Updated ALISCA-Breast1 data: Management said updated data from ALISCA-Breast1 is planned for Q4 2026. Source
Figures management reported
| Figure | Reported |
|---|---|
| NERLYNX net product revenue, Q1 2026 Source | $42.0 million (Q1 2025: $43.1 million) |
| Royalty revenue, Q1 2026 Source | $2.8 million (Q1 2025: $2.9 million) |
| R&D spend, Q1 2026 Source | $19.8 million (Q1 2025: $13.8 million) |
| Alisertib pipeline milestones Source | ALISCA-Breast1 and ALISCA-Lung1 expansion H2 2026; updated ALISCA-Breast1 data Q4 2026 |
Risks management discussed
- Financial: Management tied continued alisertib development to careful management of resources, while R&D expense rose in the quarter. Source
- Demand: Gross to net adjustments reduce gross sales to net product revenue; the full-year adjustment is guided at 26.5% - 27.5%. Source
Earlier plans management reported on
- Not stated: Management said it is carefully managing resources to achieve positive net income for this year. The raised full-year net income guidance was given in this release. Source
- Not stated: The prior release listed Q2 2026 interim data presentations. This release says management is pleased with interim data from both trials, without stating a status against the earlier timing. Source
Other quarters
- Q2 FY2026 earnings call
- Q4 FY2025 earnings call
- Q3 FY2025 results
- Q2 FY2025 results
- Q3 FY2026 earnings call
Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.