PUMA BIOTECHNOLOGY, INC. Q1 FY2025 earnings call

• Clinical updates: Interim data from a Phase I trial of neratinib and Fam-trastuzumab deruxtecan in metastatic solid tumors was presented, with dose level 3 selected as the recommended Phase II dose. Updates on alisertib trials: ALISCA-Breast1 trial has 28 patients enrolled and is enrolling ahead of expectations; ALISCA-Lung1 trial is amending the protocol to increase alisertib dose. - Commercial performance: Jeff Ludwig discussed NERLYNX commercial performance, noting Q1 2025 net revenue decline due to inventory fluctuations. Marketing efforts: Heather Blaber mentioned revising sales aids, rolling out a new patient resource brochure, and focusing on expanding share of voice. Sales insights: Roger Storms talked about increasing sales rep engagement and progress on filling vacancies. - In-licensing/acquiring: Puma continues to evaluate drugs to potentially in-license or acquire to diversify.

Puma Biotechnology reported total revenue for the first quarter of 2025 of $46.0 million. Product revenue net, consisting entirely of NERLYNX sales, was $43.1 million in Q1 2025, down from $54.4 million in Q4 2024 but up from $40.3 million in Q1 2024. Royalty revenue was $2.9 million in Q1 2025, compared to $4.7 million in Q4 2024 and $3.5 million in Q1 2024. NERLYNX sales in Q1 2025 were 2,338 bottles, a decrease from 2,964 bottles in Q4 2024. New prescriptions were up approximately 6% compared to Q4 2024, while total prescriptions were down approximately 9% compared to Q4 2024. Revenue contribution: Product revenue net was the main component, making up a significant portion of the total revenue.

• Fiscal year 2025 net NERLYNX product revenue is expected to be in the range of $192 million to $198 million. - Royalty revenue for 2025 is anticipated to be in the range of $20 million to $24 million. - Full-year 2025 net income is expected to be in the range of $23 million to $28 million. - Q2 2025 NERLYNX product revenue net is expected to be in the range of $48 million to $50 million. - Q2 2025 royalty revenue is expected to be in the range of $2 million to $3 million. - SG&A expenses are anticipated to decrease by 5% to 10% in 2025 compared to 2024, while R&D expenses are expected to increase by 10% to 15%.

• Uncertainties in forward-looking statements as actual events and results may differ. - Shifting trade policies in the United States and other countries, which are difficult to predict and could impact product cost or operations. - Risks associated with clinical trials, including trial protocol amendments, potential delays in data readouts, and uncertainties in drug efficacy and safety.

Q: Could you talk about where the alisertib IP is held and manufacturing?

A: Alan Auerbach said he would get back on the IP location but noted alisertib was originally developed by Millennium in the U.S. and manufacturing is mostly in the U.S.

Q: For alisertib lung cancer Phase II trial, confirm interim data readout and response data based on current dose; for NERLYNX Phase I data, how to select tumor types and expected PFS improvement; view on Medicare Part D redesign.

A: Jeff Ludwig said they are amending the alisertib protocol to increase dose and still plan interim data later in 2025; on NERLYNX, encouraged by Phase I data but need more data to determine PFS improvement; on Medicare Part D redesign, co-pays for patients have declined and are expected to decline further, making it more affordable for patients to stay on NERLYNX.