Puma Biotechnology ((PBYI)) has held its Q4 earnings call. Read on for the main highlights of the call.
During the latest earnings call, Puma Biotechnology conveyed a mixed sentiment, highlighting significant achievements in clinical trials and regulatory approvals, while also addressing challenges related to revenue and prescription declines. The company maintained a positive net income, but concerns were raised due to a drop in royalty revenue and NERLYNX net product revenue.
Increased NERLYNX Bottle Sales
NERLYNX ex-factory bottle sales saw a notable increase in the fourth quarter of 2024, reaching 2,964 bottles. This represents an approximate 9% increase quarter-over-quarter and a 3% increase year-over-year, indicating a positive trend in product distribution.
New Regulatory Approvals
The company achieved significant milestones with NERLYNX receiving regulatory approval in Turkey for the extended adjuvant setting and in Thailand for both extended adjuvant and metastatic breast cancer. These approvals are expected to enhance market penetration and revenue streams in these regions.
Positive Net Income
Puma Biotechnology reported a net income of $19.3 million for the fourth quarter of 2024, translating to $0.39 per share. The company anticipates maintaining a positive net income for the full year 2025, projected to be between $23 million and $28 million.
Revenue Growth in Specialty Distributor Channel
The addition of BioCare to Puma’s specialty distributor network has bolstered revenue growth, driven by community oncologists. This strategic move supports a significant portion of the business and enhances the distribution of NERLYNX.
Ongoing Clinical Trials Progress
Puma Biotechnology is making strides in its clinical trials, with a Phase 1 trial for neratinib and trastuzumab deruxtecan, and two Phase 2 trials for alisertib in breast and lung cancer. Interim data from these trials is expected in 2025, which could potentially lead to new treatment options.
Decline in NERLYNX Net Product Revenue
Despite the increase in bottle sales, NERLYNX net product revenue in Q4 2024 was $54.4 million, marking a decline of $1.7 million from Q3 2024. This decrease highlights ongoing challenges in revenue generation.
Significant Drop in Royalty Revenue
Royalty revenue experienced a sharp decline in Q4 2024, falling to $4.7 million from $24.4 million in Q3 2024. This drop was primarily due to reduced sales to China by the licensing partner Pierre Fabre.
Challenges with Inventory and Prescriptions
The company faced challenges with inventory and prescriptions, as new prescriptions (NRx) decreased by 7% quarter-over-quarter, and enrollments declined by 7% quarter-over-quarter and about 10% year-over-year. These declines indicate potential issues in market demand and patient acquisition.
Forward-Looking Guidance
For fiscal year 2025, Puma Biotechnology projects NERLYNX product revenue net to be between $192 million and $198 million, with a gross to net adjustment between 20.5% and 21.5%. The company also expects royalties to range from $20 million to $24 million and forecasts net income for the year to be between $23 million and $28 million.
In summary, Puma Biotechnology’s earnings call reflected a blend of optimism and caution. While the company celebrated regulatory approvals and clinical progress, it also acknowledged challenges in revenue and prescription metrics. Looking ahead, Puma remains focused on achieving its financial targets for 2025, despite the hurdles it faces in the market.