Puma Biotech (NASDAQ: PBYI) reported Q4 EPS of ($0.14), $0.15 better than the analyst estimate of ($0.29). Revenue for the quarter came in at $52.6 million versus the consensus estimate of $52.79 million.

“During the fourth quarter of 2020 Puma continued to be negatively impacted by the challenges of COVID-19; however, we were pleased to be able to achieve NERLYNX revenues that were within the previously stated guidance,” said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. “Our year concluded with a number of positive clinical milestones for the Company, including the publication of ExteNET data in Clinical Breast Cancer, a research collaboration with NCCN Oncology, the announcement of interim SUMMIT data in exon 18 mutated non-small cell lung cancer, and the presentation of neratinib data at the San Antonio Breast Cancer Symposium across multiple spotlight and traditional poster presentations. Although we anticipate that COVID-19 may continue to impact our operations in 2021, we remain focused on and committed to providing support to patients battling breast cancer.”

Mr. Auerbach added, “We anticipate the following key milestones over the next 12 months: (i) 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; (ii) 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; (iii) 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; (iv) 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; (v) 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; (vi) conducting a meeting with the FDA to discuss the potential for an accelerated approval pathway for neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations who have been previously treated with an EGFR tyrosine kinase inhibitor in 2021; and (vii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries in 2021.”

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