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Dec 31, 2019
Puma Biotechnology Q4 2019 Earnings Report
Puma Biotechnology reported a net loss for Q4 2019, with a decrease in product revenue compared to Q4 2018, but non-GAAP adjusted net income was positive.
Key Takeaways
Puma Biotechnology reported a net loss of $11.2 million for the fourth quarter of 2019, compared to a net loss of $30.7 million for the fourth quarter of 2018. Net product revenue in the fourth quarter of 2019 was $58.7 million, compared to $61.1 million in the fourth quarter of 2018. Non-GAAP adjusted net income was $0.3 million, compared to a non-GAAP adjusted net loss of $12.2 million for the fourth quarter of 2018.
Puma Biotechnology reported a net loss of $11.2 million, or $0.29 per share, for Q4 2019.
Non-GAAP adjusted net income was $0.3 million, or $0.01 per share, for Q4 2019.
Net product revenue for Q4 2019 was $58.7 million, a decrease compared to $61.1 million in Q4 2018.
Total revenue for Q4 2019 was $62.9 million, including product, license, and royalty revenue.
Revenue by Segment
Forward Guidance
Puma anticipates several key milestones over the next 12 months, including modifying the SUMMIT basket trial, receiving a regulatory decision on neratinib in third-line HER2-positive metastatic breast cancer, conducting a pre-NDA meeting with the FDA, reporting Phase II data from the SUMMIT trial, reporting additional data from the Phase II CONTROL trial, and receiving regulatory decisions for an extended adjuvant HER2-positive early stage breast cancer indication in additional countries.
Positive Outlook
- Modifying the SUMMIT basket trial to expand the HER2-mutated breast cancer cohort in Q1 2020.
- Receiving a [U.S.] regulatory decision on neratinib in third-line HER2-positive metastatic breast cancer in Q2 2020.
- Conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2 mutated hormone receptor positive breast cancer and HER2 mutated cervical cancer in Q4 2020.
- Reporting Phase II data from the HER-positive breast and cervical cancer cohorts from the SUMMIT trial of neratinib in patients with HER2 mutations in Q4 2020.
- Reporting additional data from the Phase II CONTROL trial in Q4 2020.
Revenue & Expenses
Visualization of income flow from segment revenue to net income
Historical Earnings Impact
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Avg. Return Before/After Earnings
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