NCE Status Won't Matter for Keryx Biopharma (KERX) - Roth Capital

Roth Capital affirms Keryx Biopharmaceuticals (Nasdaq: KERX) at Buy with a price target of $32, believing that NCE status for Ferric Citrate is irrelevant.

Analyst Joseph Pantginis commented, If NCE status is not granted on the Friday Orange Book update, the stock may experience some weakness, though we believe short lived, based on lack of action by the FDA. We do not believe that NCE status is necessary for Ferric Citrate to take advantage of its differentiated properties and will be a successful launch. The primary thesis (discussed further below), in our belief, to lack of NCE importance are the high barriers to entry to potential generic filers. We also believe an important piece of evidence facing potential generic competitors is that generics for Renvela were able to be made since March 2014. None are available yet. Generally a generic filer would be ready to go on day one, not seven months later. We also put forth that whether there is a generic Renvela, or other phosphate binder for that matter, they do not possess the differentiated iron sparing properties of Ferric Citrate. Recall that KERX released the Ferric Citrate wholesale annual cost (WAC) per pill. The pricing will be $4.21 per pill and the dosing regimen was ~8 pills per day in the Phase III. For comparison competitors' pricing and dosing regimens are: 1) Renvela – 8-9 pills per day; WAC: $3.86 per pill, 2) Fosrenol – 3-4 pills per day; WAC: $8.65 per pill, 3) Velphoro - 3-4 pills per day; WAC: $9.50 per pill.

For an analyst ratings summary and ratings history on Keryx Biopharmaceuticals click here. For more ratings news on Keryx Biopharmaceuticals click here.

Keryx Biopharmaceuticals closed at $14.98 yesterday.

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