KemPharm (KMPH) Tops Q1 EPS by 26c

KemPharm (NASDAQ: KMPH) reported Q1 EPS of ($0.20), $0.26 better than the analyst estimate of ($0.46).

“This has been a significant period for KemPharm. Last week’s joint advisory committee meeting with the FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management committees voted in support of approving Apadaz for the management of acute pain that requires an opioid, yet recommended against including abuse deterrent labeling for the product,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “While the committees’ advice regarding potential product labeling is disappointing, we continue to work collaboratively with the FDA as it continues its priority review of Apadaz as we look ahead to the target action date on June 9, 2016.”

“Earlier this week we received Fast Track designation by the FDA for KP511, our prodrug of hydromorphone, for the treatment of moderate-to-severe pain where an opioid is appropriate, and we now anticipate sharing proof-of-concept study data of KP511 as early as the second quarter of 2016. We believe these are positive steps forward with this program and demonstrate the continued development of our pipeline of proprietary prodrugs. Our plan is to develop KP511 as an extended-release prodrug product candidate – KP511/ER – that could offer the potential to deter certain methods of abuse while providing the same pharmacokinetic and therapeutic effect as existing hydromorphone products when taken as intended.”

“Lastly, we anticipate achieving several milestones in 2016 in the development of KP201/IR, our acetaminophen-free hydrocodone prodrug,” Dr. Mickle concluded. “We expect to progress this program into a potential NDA filing during 2017 as we continue to advance our pipeline in a planned effort to submit at least one new NDA each year through 2019.”

For earnings history and earnings-related data on KemPharm (KMPH) click here.

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