Leerink’s Michael Schmidt and Varun Kumarreiterated an Outperform rating on the stock today, writing that while the approval isn’t a surprise, it has removed an overhang for the stock, and it came in earlier than expected to boot.
More detail from their note:
The product label looks broad, not restricting use to specific patient populations (e.g., hormone-receptor [HR] positive patients) and there is no black box warning. The prescribing information contains fairly detailed information about the use of antidiarrheal prophylaxis measures, providing specific information on how to manage the drug’s main side effect. Information on pricing and launch timing is not available yet; PBYI previously guided to a cost of therapy that is similar to that of other breast cancer drugs. We’d expect a US launch not immediately given that PBYI has hired a US sales force only contingent on obtaining regulatory approval. A recommendation from the European CHMP is still pending and expected later this month or next. We currently model $1.3Bn US Nerlynx peak sales in the extended adjuvant treatment setting based on relatively conservative assumptions and believe 2018E Street consensus of $215M should be achievable.
[Source:-.barrons]