Zogenix, Inc. (NASDAQ:ZGNX) had a loss and missed Wall Street’s expectations, AND came up short on beating the revenue expectation. The revenue miss is a negative sign to shareholders seeking high growth out of the company. Shares are down 2.41%.
Zogenix, Inc. Earnings Cheat Sheet
Results: Adjusted Earnings Per Share decreased to $-0.17 in the quarter versus EPS of $-0.16 in the year-earlier quarter.
Revenue: Decreased 61.96% to $6.98 million from the year-earlier quarter.
Actual vs. Wall St. Expectations: Zogenix, Inc. reported adjusted EPS loss of $0.17 per share. By that measure, the company missed the mean analyst estimate of $-0.14. It missed the average revenue estimate of $9.28 million.
Quoting Management: Roger Hawley, chief executive officer of Zogenix, stated, “We recently had an update call with the FDA regarding the status of the Zohydro ER new drug application (NDA). On the call, the FDA indicated that they are preparing to take action on the Zohydro NDA in the summer 2013. While they declined to provide any specific reasons for the delay, we have concluded the FDA are working on several broader opioid-related issues that need to be addressed prior to an action on our NDA. We were not informed of any deficiencies in the application, which suggests that the remaining steps in the review process are finalizing the Zohydro ER REMS, to be consistent with the updated class-wide REMS, and labeling discussions. We are disappointed with the ongoing delay, and remain prepared to launch the product three to four months after potential approval.”
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