Puma Biotechnology (PBYI) Q2 2024 earnings summary

Executive summary

• Q2 2024 total revenue was $47.1 million, with net product revenue from NERLYNX at $44.4 million, down 14% year-over-year but up 10% sequentially; royalty revenue was $2.7 million.

• GAAP net loss for Q2 2024 was $4.5 million ($0.09 per share), compared to net income of $2.1 million in Q2 2023; non-GAAP net loss was $2.5 million ($0.05 per share).

• NERLYNX bottle sales were 2,515 in Q2 2024, up 4% quarter-over-quarter but down 17% year-over-year; new prescriptions decreased 9% sequentially and 10% year-over-year.

• Inventory drawdown impacted Q2 results, with a $2.3 million reduction.

• Promising efficacy signals reported from alisertib clinical studies in lung and breast cancer; new trials and interim data expected in Q4 2024.

Financial highlights

• Gross revenue from NERLYNX sales was $55.8 million in Q2 2024; gross-to-net adjustment was 20.4%, down from 23.4% in Q1 2024.

• Cost of sales for Q2 2024 was $10.7 million, down from $11.9 million in Q2 2023; SG&A expenses were $25 million, R&D expenses were $13.6 million.

• Operating costs and expenses for Q2 2024 were $49.3 million, nearly flat year-over-year.

• Cash, cash equivalents, and marketable securities were $96.8 million as of June 30, 2024.

• Gross margin for Q2 2024 was approximately 77%.

Outlook and guidance

• FY 2024 net NERLYNX product revenue expected between $183 million-$190 million; royalty revenue $30 million-$33 million; net income $12 million-$15 million.

• Q3 2024 NERLYNX net product revenue expected at $50 million-$53 million, including ~$6 million from global partners; royalty revenue $20 million-$22 million; gross-to-net adjustment 18.5%-19.5%.

• Key clinical milestones in next 12 months: initiation of ALISCA-Breast1 (Q4 2024) and interim data from ALISCA-Lung1 (Q4 2024).

• Existing cash, equivalents, and marketable securities expected to cover operating needs for at least one year.

• Company remains dependent on successful commercialization of NERLYNX and development of alisertib.