Puma Biotechnology — Second Quarter 2026 Earnings Summary

Financial Performance

• Total revenue for Q2 2026 was $56.5 million, up from $52.4 million in Q2 2025, driven by product revenue, net of $53.6 million compared to $49.2 million in the prior year period.
• Product revenue, net for the first six months of 2026 was $95.5 million, compared to $92.3 million in the first six months of 2025.
• GAAP net income for Q2 2026 was $8.2 million ($0.16 per basic and diluted share), compared to $5.9 million ($0.12 per basic and diluted share) in Q2 2025.
• GAAP net income for the first six months of 2026 was $4.4 million ($0.09 per basic and diluted share), a decrease from $8.8 million ($0.18 per basic and diluted share) in the first six months of 2025.
• Non-GAAP adjusted net income for Q2 2026 was $10.1 million ($0.20 per basic share, $0.19 per diluted share), compared to $7.5 million ($0.15 per basic and diluted share) in Q2 2025.
• Non-GAAP adjusted net income for the first six months of 2026 was $8.3 million ($0.16 per basic and diluted share), compared to $12.4 million ($0.25 per basic and diluted share) in the first six months of 2025.
• Net cash provided by operating activities for Q2 2026 was $1.6 million, compared to $14.1 million in Q2 2025; for the first six months of 2026, it was $17.0 million, compared to $17.7 million in the same period in 2025.
• Outstanding debt was reduced to zero as of June 30, 2026, following the final payment of principal, interest, and exit fees under the 2021 Note Purchase Agreement on May 4, 2026.
• Cash, cash equivalents, and marketable securities totaled $93.9 million at June 30, 2026, compared to $97.5 million at December 31, 2025.
• Total operating costs and expenses were $48.9 million for Q2 2026, up from $45.8 million in Q2 2025; for the first six months of 2026, they were $97.5 million, up from $87.8 million in the prior year period.
• Research and development expenses were $18.9 million for Q2 2026 (up from $15.5 million in Q2 2025) and $38.7 million for the first six months of 2026 (up from $29.3 million in the first six months of 2025).
• Selling, general and administrative expenses were $17.5 million for Q2 2026 (down from $18.0 million in Q2 2025) and $35.9 million for the first six months of 2026 (up from $35.6 million in the first six months of 2025).
• Cost of sales was $12.5 million for Q2 2026 (up from $12.3 million in Q2 2025) and $22.9 million for the first six months of 2026 (unchanged from the first six months of 2025).
• Total other income was $0.6 million for Q2 2026, compared to total other expenses of $0.4 million in Q2 2025; for the first six months of 2026, total other income was $1.0 million, compared to total other expenses of $1.2 million in the first six months of 2025.

Guidance and Future Outlook

• Puma raised its full-year 2026 net product revenue guidance to $205–$209 million (prior guidance: $202–$206 million) and total revenue guidance to $224–$231 million (prior guidance: $222–$229 million).
• The company raised its full-year 2026 net income guidance to $17–$20 million (prior guidance: $16–$19 million).
• Third Quarter 2026 guidance includes net product revenue of $54–$56 million, royalty revenue of $2–$3 million, total revenue of $56–$59 million, and net income of $2–$3.5 million.
• Full-year 2026 gross-to-net adjustment is expected to be 26.5%–27.5%.
• Key milestones anticipated over the next 12 months include: initiation of enrollment in ALISCA-Lung2 (Q3 2026), expansion of enrollment in ALISCA-Breast1 (H2 2026), expansion of ALISCA-Lung1 (H2 2026), and presentation of updated data from ALISCA-Breast1 (Q4 2026).

Business Segments and Product Lines

• Product revenue, net consists entirely of sales of NERLYNX, Puma's first commercial product.
• Royalty revenue was $2.9 million in Q2 2026 (down from $3.2 million in Q2 2025) and $5.8 million for the first six months of 2026 (down from $6.1 million in the first six months of 2025).
• Clinical development programs for alisertib are progressing, with increased activity in ALISCA trials for HER2-negative, hormone receptor-positive metastatic breast cancer and small cell lung cancer.
• The increase in R&D expenses for the first six months of 2026 was primarily driven by a $7.4 million increase in clinical trial expense and a $2.0 million increase in internal R&D expense, including employee compensation and the hiring of a new executive.

Market and Competitive Landscape

• Management reported a continued increase in year-over-year demand for NERLYNX.
• Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and financial assistance resources.

Risks and Challenges

• Forward-looking statements involve risks and uncertainties, including adverse impacts on the business or global economy, changes in regulatory approvals, clinical trial results, litigation, and changes to in-licensed intellectual property.
• Actual results could differ materially from anticipated results due to factors disclosed in periodic reports filed with the SEC.

Management Commentary and Tone

• Alan H. Auerbach, Chairman, CEO, and President, expressed pleasure with commercial execution and the continued increase in demand for NERLYNX.
• Management remains focused on continuing commercial execution in the second half of the year and advancing alisertib in clinical trials.
• The tone indicates confidence in the commercial performance of NERLYNX and the progression of the clinical pipeline.

Other Key Points

• Puma terminated all remaining obligations under its 2021 Note Purchase Agreement on May 4, 2026, reducing outstanding debt to zero.
• The company will host a conference call on August 6, 2026, at 1:30 p.m. PDT to discuss results and outlook.
• NERLYNX is approved for extended adjuvant treatment of early stage HER2-overexpressed/amplified breast cancer and for advanced or metastatic HER2-positive breast cancer in combination with capecitabine.
• Alisertib is a selective, small molecule, orally administered inhibitor of aurora kinase A, with development focused on small cell lung cancer and breast cancer.