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Dec 31, 2020
Puma Biotechnology Q4 2020 Earnings Report
Puma Biotechnology reported a net loss for Q4 2020, impacted by COVID-19 challenges, but achieved NERLYNX revenues within guidance.
Key Takeaways
Puma Biotechnology reported a net loss of $15.0 million for the fourth quarter of 2020, with NERLYNX revenue at $50.0 million. The company continued to be impacted by COVID-19 challenges but met revenue guidance. Positive clinical milestones were achieved, and key milestones are anticipated over the next 12 months.
Net NERLYNX revenue for Q4 2020 was $50.0 million, compared to $58.7 million in Q4 2019.
Puma reported a net loss of $15.0 million, or $0.38 per share, for Q4 2020, compared to a net loss of $11.2 million, or $0.29 per share, for Q4 2019.
Non-GAAP adjusted net loss was $5.5 million, or $0.14 per share, for Q4 2020, compared to non-GAAP adjusted net income of $0.3 million, or $0.01 per share, for Q4 2019.
Net cash used in operating activities for Q4 2020 was $5.6 million, compared to net cash provided by operating activities of $1.6 million for Q4 2019.
Forward Guidance
Puma anticipates key milestones over the next 12 months, including completing enrollment and reporting top line data from the randomized cohort in the Phase II SUMMIT trial, conducting a pre-NDA meeting with the FDA, reporting Phase II data from the SUMMIT trial in non-small cell lung cancer patients, reporting data from the Phase II TBCRC-022 trial, conducting a meeting with the FDA to discuss the potential for an accelerated approval pathway, and receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries.
Positive Outlook
- Completing enrollment in the randomized cohort in the Phase II SUMMIT trial of neratinib in hormone receptor positive breast cancer that has a HER2 mutation in the second quarter of 2021
- Reporting top line data from the randomized cohort in the Phase II SUMMIT trial of neratinib in hormone receptor positive breast cancer that has a HER2 mutation in 2021
- 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 2021
- Reporting Phase II data from the SUMMIT trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations in the second half of 2021
- Reporting data from the Phase II TBCRC-022 trial of the combination of Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla in the second half of 2021
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