KemPharm reports Q1 EPS (46c), consensus (46c)
Total cash, cash equivalents and restricted cash was $14M at March 31. "The first quarter of 2019 and early April were highlighted by advancements in our KP415 and APADAZ(R) programs, serving to propel each towards what we believe will be significant value building events in the coming months," said Travis Mickle CEO of KemPharm. "For KP415, our prodrug product candidate being developed for the treatment of attention-deficit/hyperactivity disorder (ADHD), we announced the completion of the pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA). We have recently received the minutes from that meeting which confirm the previously reported results. In summary, we believe the review of the KP415 pre-NDA briefing package, which included clinical, non-clinical and human abuse potential study results, as well as regulatory elements, was consistent with our interpretation and previous interactions with the FDA, and, as a result, we believe that we are positioned to submit the KP415 NDA in late second quarter or early third quarter 2019.In parallel with the regulatory activities for KP415, we have entered into what we believe are the final stages of the partnering process for our ADHD franchise, which includes KP415 and KP484," continued Mickle. "Since the initiation of the partnering process, our goal has been focused on securing an agreement with a partner fully dedicated to maximizing the commercial value of KP415 and KP484. While still engaged with multiple parties, we believe that the process should be complete sometime later this quarter or early third quarter."