Zogenix Received FDA Approval, Now What?

On January 30, Zogenix ZGNX received FDA approval for its reformulated version of Zohydro ER.

The new version of Zohydro ER utilizes BeadTek, which has abuse deterrent properties. The company has ongoing Human Abuse Liability studies that will be submitted to the FDA in the second half of 2015.

The company hopes that they will be able to amend the labeling on the current Zohydro ER label.

Zogenix has stated that it expects to roll out the new formulation of Zohydro ER in the second quarter. It is likely that the company announces a secondary offering in the near future to fund the rollout.

On January 20, the company put its S-3 into EFFECT. Under the S-3, the company has the ability to raise up to $100 million through a secondary public offering with Cantor Fitzgerald.
According to most recent filings, the company has about $50 million in cash and burns about $80 million.

Long term, a successful rollout could be a positive, as the new formulation has the potential to bring in larger revenues.

The company is also developing Brabafen for Dravet syndrome and Relday for schizophrenia.

At the time of approval, approximately 15.5 percent of the float was held short.

On December 29, Brean Capital put a $2.50 price target on Zogenix stock.