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, up from $40.3 million in Q1 2024 but down from $51.6 million in Q2 2023.

• Net loss for Q2 2024 was $4.5 million GAAP ($0.09/share) and $2.5 million non-GAAP ($0.05/share), both improved from Q1 2024 but down from net income in Q2 2023.

• NERLYNX bottle sales increased 4% quarter-over-quarter to 2,515 but declined 17% year-over-year; new patient starts fell 9% quarter-over-quarter and 10% year-over-year.

• Cash, cash equivalents, and marketable securities totaled $96.8 million at June 30, 2024.

• 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, up from $52.6 million in Q1 2024.

• Gross-to-net adjustment improved to 20.4% in Q2 2024 from 23.4% in Q1 2024.

• Cost of sales was $10.7 million, including $2.4 million amortization of intangible assets.

• SG&A expenses rose to $25 million in Q2 2024 from $21.8 million in Q1 2024; R&D expenses were flat at $13.6 million.

• Operating costs and expenses for Q2 2024 were $49.3 million, nearly flat versus $49.7 million in Q2 2023.

Outlook and guidance

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

• Q3 2024 net product revenue guidance is $50 million-$53 million, with U.S. revenue at $44 million-$47 million; royalty revenue expected at $20 million-$22 million, driven by a large shipment to China.

• 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.

• SG&A expenses anticipated to decrease 8%-12% and R&D expenses to increase 16%-19% year-over-year.