Puma Biotechnology — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for Q3 2026 was $55.1 million, up from $54.5 million in Q3 2025; product revenue, net was $54.1 million (vs. $51.9 million), and royalty revenue was $1.0 million (vs. $2.6 million).
• Total revenue for the first nine months of 2026 was $156.4 million, up from $152.9 million in the same period of 2025; product revenue, net was $149.6 million (vs. $144.2 million), and royalty revenue was $6.8 million (vs. $8.7 million).
• Q3 2026 included a $2.1 million reduction to royalty revenue due to a change in accounting estimate regarding generic NERLYNX market share in China.
• GAAP net income for Q3 2026 was $6.0 million ($0.12 basic, $0.11 diluted per share), compared to $8.8 million ($0.18 basic, $0.17 diluted) in Q3 2025.
• GAAP net income for the first nine months of 2026 was $10.4 million ($0.20 per share), compared to $17.7 million ($0.35 per share) in the first nine months of 2025.
• Non-GAAP adjusted net income for Q3 2026 was $8.0 million ($0.15 per share), compared to $10.5 million ($0.21 per share) in Q3 2025.
• Non-GAAP adjusted net income for the first nine months of 2026 was $16.3 million ($0.32 basic, $0.31 diluted per share), compared to $23.0 million ($0.46 per share) in the first nine months of 2025.
• Net cash provided by operating activities was $14.6 million in Q3 2026 (vs. $9.7 million in Q3 2025) and $31.6 million for the first nine months of 2026 (vs. $27.4 million).
• Cash, cash equivalents, and marketable securities totaled $108.5 million at September 30, 2026, compared to $97.5 million at December 31, 2025.
• Total operating costs and expenses were $49.8 million in Q3 2026 (vs. $44.9 million) and $147.4 million for the first nine months (vs. $132.7 million).
• Cost of sales was $15.2 million in Q3 2026 (vs. $12.2 million) and $38.1 million for the first nine months (vs. $35.0 million), driven by higher sales to an international partner.
• R&D expenses were $18.3 million in Q3 2026 (vs. $15.9 million) and $57.0 million for the first nine months (vs. $45.2 million), with the year-to-date increase attributed to higher clinical trial expenses and internal R&D compensation.
• SG&A expenses were $16.3 million in Q3 2026 (vs. $16.8 million) and $52.3 million for the first nine months (vs. $52.5 million).
• Total other income was $0.9 million in Q3 2026 (vs. $0.4 million expense) and $2.0 million for the first nine months (vs. $1.5 million expense), primarily due to a decrease in interest expense following debt principal repayment in May 2026.
• Current portion of long-term debt was $0 at September 30, 2026, down from $22.5 million at December 31, 2025.

Guidance and Future Outlook:

• Raised full-year 2026 net income guidance to $20–$22 million from a prior range of $17–$20 million.
• Q4 2026 net product revenue guidance is $56–$58 million; royalty revenue is $11–$12 million; total revenue is $67–$70 million.
• Full-year 2026 net product revenue guidance is $206–$208 million; royalty revenue is $18–$19 million; total revenue is $224–$227 million.
• Full-year 2026 gross to net adjustment guidance is 27.5%–28%, up from a prior range of 26.5%–27.5%.
• Management anticipates increased year-over-year demand for NERLYNX.
• Key milestones over the next 12 months include: presentation of updated data from ALISCA-Breast1 at the San Antonio Breast Cancer Symposium (December 2026); initiation of discussions with global regulatory agencies regarding Phase III trial design for alisertib in breast cancer (H1 2027); continued enrollment in ALISCA-Breast1 (H2 2026); continued enrollment in ALISCA-Lung1 and ALISCA-Lung2 (Q4 2026); and presentation of updated data from ALISCA-Lung1 (2027).

Business Segments and Product Lines:

• NERLYNX is the company's only commercial product, generating all product revenue.
• U.S. NERLYNX sales were positively impacted by increased year-over-year demand but negatively impacted by higher-than-expected gross-to-net due to increased Medicaid and 340B sales.
• Sales to ex-U.S. commercial partners were delayed from Q3 to Q4 2026.
• Cost of sales increases were driven by higher product sales to an international partner.
• Alisertib clinical development programs (ALISCA) are advancing across lung and breast cancer indications.
• Initiated ALISCA-Lung2, a Phase II trial evaluating alisertib in combination with paclitaxel for advanced small cell lung cancer, in September 2026.
• Continuing enrollment in ALISCA-Breast1 (Phase II, alisertib with endocrine treatment for HER2-negative, HR-positive metastatic breast cancer) and ALISCA-Lung1 (Phase II, alisertib monotherapy for extensive stage small cell lung cancer).

Market and Competitive Landscape:

• Generic versions of NERLYNX in China reached a specified market share threshold during the period, triggering a change in accounting estimate that reduced royalty revenue.
• The company faces competition from generic versions of NERLYNX, which impacts royalty revenue calculations.

Risks and Challenges:

• Gross-to-net adjustments were higher than expected due to increased Medicaid and 340B sales.
• Sales delays to ex-U.S. commercial partners shifted revenue from Q3 to Q4.
• Unfavorable exchange rates on Euro-denominated transactions negatively impacted other income.
• Termination of subleases as of March 31, 2026, impacted other income.
• Forward-looking statements involve risks including adverse impacts on the business or global economy, changes in regulatory approvals, clinical trial results, litigation, and intellectual property changes.

Management Commentary and Tone:

• Alan H. Auerbach, Chairman, CEO, and President, stated that Q3 U.S. NERLYNX sales were positively impacted by increased demand despite gross-to-net headwinds and international sales delays.
• Management expressed confidence in anticipating increased year-over-year demand for NERLYNX.
• Management highlighted the expansion of the alisertib clinical development program with the initiation of the Lung2 trial.
• The tone reflects confidence in the raised net income guidance and the progression of clinical milestones.

Other Key Points:

• Puma paid down its debt principal in May 2026, resulting in a lower debt balance and decreased interest expense.
• Stock-based compensation represented approximately 5.8% of operating expenses in Q3 2026 and 5.4% for the first nine months of 2026.
• The company hosts a conference call on November 5, 2026, at 1:30 p.m. PT to discuss results.
• Puma Patient Lynx support program assists patients with reimbursement and financial assistance.
• Working capital increased to $105.7 million at September 30, 2026, from $81.4 million at December 31, 2025.
• Stockholders' equity increased to $146.6 million at September 30, 2026, from $130.3 million at December 31, 2025.