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Thursday, May 9, 2019

=Puma Biotech. (PBYI) reported earnings on Thur 9 May 2019 (a/h)



Puma Biotech. beats by $0.41, beats on revs
  • Reports Q1 (Mar) earnings of $0.21 per share, $0.41 better than the single analyst estimate of ($0.20); revenues rose 49.0% year/year to $99.1 mln vs the $67.25 mln S&P Capital IQ Consensus.
  • Commentary: "During 2019, we anticipate the following key milestones for Puma: presenting data from the Phase III trial of neratinib in third-line metastatic breast cancer patients in the second quarter of 2019; filing a new drug application for neratinib based on the results of the Phase III trial in third-line metastatic breast cancer in the summer of 2019; meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the summer of 2019; receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in other countries in the second half of 2019; reporting additional data from the Phase II CONTROL trial in the second quarter of 2019; and reporting Phase II data from the SUMMIT basket trial in patients with HER2 mutations in the second half of 2019."
Puma Biotech investors dump the stock after sales breast cancer drug NERLYNX fall 25% sequentially
Shares of Puma Biotech (PBYI) -36% are getting crushed after the company reported disappointing sales of its breast cancer drug NERLYNX, its first commercial product on the market.
Net NERLYNX revenue in the first quarter of $45.6 mln grew 27% yr/yr but fell 25% qtr/qtr in the seventh quarter since the drug's launch in 3Q17. New drugs don't experience seasonality like other industries that see a sequential decline from the fourth quarter to the first quarter, so a sequential decline is worrisome for investors.
The company said that there was an increase in patients discontinuing use of the drug due to its side effects. A key concern for the drug even before approval was diarrhea.
Management said that it continues to educate physicians and patients about the importance of antidiarrheal medicine along with the NERLYNX as some physicians don't prescribe antidiarrheal medicine and some patients don't fill the prescription.
The stock got crushed on disappointing 3Q18 NETLYNX sales in November as well.
Cantor Fitzgerald and Citigroup downgraded the stock this morning.
Puma has a ~$700 mln market value with the stock testing late 2018 lows down ~36% premarket.

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