PUMA BIOTECHNOLOGY, INC. Q4 FY2024 earnings call

• Clinical Review: There's an ongoing Phase 1 trial sponsored by the National Cancer Institute evaluating neratinib and trastuzumab deruxtecan in HER2-positive metastatic solid tumors, with interim data expected in H1 2025. Two ongoing Phase 2 trials for alisertib: ALISCA-Breast1 (alisertib + endocrine treatment in chemo-naïve HER2-negative HR+ metastatic breast cancer) with 22 sites activated and 14 patients enrolled, and ALISCA-Lung1 (alisertib monotherapy in small cell lung cancer) with the Steering Committee recommending expanding enrollment to patients with more prior treatments. - Commercial Performance: Q4 call activity decreased QoQ but increased YoY. NERLYNX ex-factory bottle sales were 2,964 in Q4 2024, with inventory increasing by ~205 bottles. New prescriptions down ~7% QoQ but up ~10% YoY, total prescriptions up ~4% QoQ. 74% of patients started NERLYNX at a reduced dose in Q4. NERLYNX received regulatory approvals in extended adjuvant setting in Turkey and Thailand, and was commercially launched in extended adjuvant setting in Turkey and Saudi Arabia. - In-Licensing: Puma continues to evaluate several drugs to potentially in-license to diversify and leverage existing infrastructure.

Total revenue for the fourth quarter of 2024 was $59.1 million. Product revenue net, consisting entirely of NERLYNX sales and royalties, was $54.4 million in Q4 2024, down from $56.1 million in Q3 2024 but up from $53.2 million in Q4 2023. Royalty revenue was $4.7 million in Q4 2024, significantly lower than $24.4 million in Q3 2024 and $19.0 million in Q4 2023. NERLYNX ex-factory bottle sales in Q4 2024 were 2,964, representing a ~9% quarter-over-quarter increase and a ~3% year-over-year increase. Product revenue for Q4 2024 was impacted by approximately $3.7 million of inventory increase at specialty pharmacies and distributors. Royalty revenue in Q4 2024 was lower due to fewer shipments to China as the partner works through regulatory transitions.

• For fiscal year 2025, net NERLYNX product revenue is expected to be in the range of $192 million to $198 million, gross to net adjustment between 20.5% and 21.5%, royalties from partners in range of $20 million to $24 million. - For Q1 2025, NERLYNX product revenue net is expected to be in range of $41 million to $43 million, royalty revenues in range of $1.5 million to $2.5 million, and Q1 net loss between $2 million and breakeven. - Anticipates flat to slightly lower total operating expenses in 2025 compared to 2024, with SG&A expenses decreasing 5%-10% and R&D expenses increasing 10%-15% YoY.

• Forward-looking statements are subject to risks and uncertainties where actual events and results may differ from those expressed. - Uncertainties in clinical trial outcomes, including timing and efficacy of interim data from Phase 1 and Phase 2 trials. - Market dynamics and regulatory changes that could impact commercial performance and royalty streams, such as regulatory transitions in China affecting royalty revenue.

Q: When will the interim data from the Phase 1 trial with the National Cancer Institute be presented?

A: Anticipated to be presented in the first half of 2025, likely at AACR or ASCO.

Q: Can you give statistics on persistence and compliance with NERLYNX?

A: Educating customers on clinical data showing benefits of patients staying on therapy >11 months, working with SP partners and sales reps, and dose escalation (74% of patients started at reduced dose in Q4) contributes to persistence and compliance.

Q: How is price versus volume considered in the revenue guidance?

A: There was a 7% price increase in early Q1 2025, forecasting demand decline of about 2% YoY, with efforts to exceed this forecast.

Q: How is the royalty stream from China expected?

A: Royalties from China are lumpy as it's sold through a distribution network, with shipments expected to be lower in 2025 due to regulatory transitions, but in-market demand in China is still forecasted to grow.