STOCK GOODIES PLAYS OF THE WEEK

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Lpath, Inc.: Drug Approval Decision

LPCN 1021, Lipocine Inc’s (NASDAQ:LPCN) lead product candidate, also known as Tlando, is an oral testosterone supplement for adult males with a deficiency or absence of endogenous testosterone. It is currently under FDA review with a deadline of June 28 to be approved or denied. Analysts are encouraged that the FDA has not called for an Advisory Committee meeting. Lipocine has $38.2 million in cash without any FDA-approved products, though analysts hope that will change this month.

Michael Higgins of Roth Capital reassured that the FDA did not request an Advisory Committee meeting to discuss the drug, noting that this “encouraging signal” paves the way for Tlando approval. Coupled with recent publications highlighting the drug’s strong safety profile, Higgins has reason to be optimistic for the FDA’s decision.

Higgins continues to model a marketing partnership into his evaluation, estimating a $40 million upfront payment. He elaborates, “Management is leaving all options on the table, from launching Tlando itself, to retaining co-promotion rights to a full marketing rights agreement. We peg the odds of these marketing strategies at 15%, 25% and 60%, respectively.”

Separately, Nisha Hirani of Zacks Capital Research is also bullish on the company’s prospects with Tlando. Nisha echoes Higgins’ optimism about the FDA bypassing an Advisory Committee meeting because it means the “FDA does not need any independent expert advise regarding the LPCN 1021 data that Lipocine has submitted…Not having an AdComm will save Lipocine significant time and costs associated with hiring outside consultation for this activity.”



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