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Attention With KP-415 Is Better Than The Market's Attention On KemPharm

Kenneth Pittman profile picture
Kenneth Pittman


  • There is almost no question regarding eventual approval of KP-415 (likely in late 2019).
  • The market has put too much focus on the 30 minute and 13 hour post-hoc analysis of SKAMP scores, leading to a 42% pullback.
  • The market is ignoring the importance of Human Abuse Potential data.
  • The profile of KP-415 compares very favorably to all current MPH stimulants on the 7 key characteristics of a stimulant medication.

KP-415 Data Release

On July 9th, KemPharm (KMPH) released results for their Phase 3 study of KP-415 for the treatment of ADHD. Top-line results were positive, with the primary endpoint of mean change in SKAMP score across all time points being easily met (0.54 for placebo vs. -4.87 for KP-415; p<0.001). Even without the post-hoc analysis (which I'll get to below), this was a highly significant result. As a secondary measure, the change in SKAMP at every time point from 1 hour until 10 hours was also met. Furthermore, the PERMP showed significant improvement from 0.5 to 13 hours even without the post-hoc analysis. This data is unequivocally positive, and even without the post-hoc analysis, it gives some support to the claim that KP-415 kicks in within 30 minutes and lasts 13 hours. It most certainly kicks in within an hour and lasts 10 hours. This information alone is sufficient for FDA approval for a stimulant - especially given the Human Abuse Potential studies that I will discuss further below. I fully expect KemPharm to file an NDA in early 2019 and easily obtain approval in late 2019.

The Market Does Its Best Impression of ADHD

Despite these positive results, the market responded by slashing the market cap of KemPharm by 42%. There are two reasons cited for this. The primary one is that using the pre-specified Visit 5 baseline, the results on the SKAMP were not significant at 30 minutes or 13 hours. The secondary reason is that there are concerns about cash flow and the need for a dilutive secondary offering.

I'll address the second one of these first - KemPharm does indeed need to raise cash. However, they have multiple options at this point that do not require dilution. They have active discussions ongoing for their approved drug, Apadaz, that could generate some cash. The

This article was written by

Kenneth Pittman profile picture
I am a Physician (Board Certified in Child Psychiatry, Adult Psychiatry, and General Pediatrics) and I have been an investor in individual biotech companies for about 7 years. I first published on Seeking Alpha in 2014 and began writing regularly in mid 2017. My focus is finding value in Biotech companies while also reviewing technical aspects of their stocks.  I concentrate on Neuroscience companies and share my perspective in this area.

Analyst’s Disclosure: I am/we are long KMPH. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

I am contracted to speak for Tris Pharmaceuticals, a private company whose interests include 2 ADHD medications that were not included in this article due to this relationship. I have had ~4 marketing lunches provided to my office in the last year by Shire and Neos. I have never had direct marketing from KemPharm. I anticipate that all of these companies may/will provide additional marketing lunches in the future. I have never been paid by any of the public companies mentioned for speaking or writing articles.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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