In its first-quarter earnings conference call, Puma Biotechnology (PBYI) highlighted its cash burn of $15 million in the first quarter, which compares unfavorably to the positive cash flow of $8.0 million reported in the fourth quarter of fiscal 2018. At the end of the first quarter, the company had $48.8 million worth of cash and cash equivalents as well as $101.6 million worth of marketable securities on its balance sheet. The company didn’t include the $60 million worth of upfront milestone payments received from Pierre Fabre in its cash balance at the end of the first quarter.
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Analysts expect Puma Biotechnology’s non-GAAP EPS to change YoY by 54.56% to -$1.36 in fiscal 2019, 111.41% to $0.16 in fiscal 2020, and 1,432.54% to $2.38 in fiscal 2021.
Analysts also expect Puma Biotechnology’s non-GAAP EPS to change YoY by 91.81% to -$0.10 in the second quarter, -22.79% to -$0.45 in the third quarter, and 68.32% to -$0.25 in the fourth quarter of fiscal 2019.
On December 17, Puma Biotechnology issued a press release announcing top-line results from its phase three trial, NALA, comparing the combination regimen of Neratinib and capecitabine with that of Tykerb and capecitabine in the third-line HER2-positive metastatic breast cancer indication. According to the first-quarter earnings conference call, neratinib and capecitabine managed to demonstrate statistically significant improvement in PFS (progression-free survival) and a positive trend, although not statistically significant, in overall survival in this trial. Based on this data and the outcome of the pre-NDA meeting with the FDA, Puma Biotechnology plans to file a supplemental NDA (new drug application) seeking approval for this Neratinib-based regimen in the third-line HER2-positive metastatic breast cancer indication in June or July 2019.
Further, the company is also studying NERLYNX (neratinib) across multiple HER2 mutated tumors in an ongoing basket trial, SUMMIT. According to the first-quarter earnings conference call, HER2 mutations are found in 2% to 12% of all solid tumor cases. Puma Biotechnology plans to discuss the future development and regulatory strategy for Neratinib in HER2 mutated tumors with the FDA in fiscal 2019.