Post by JHam on Feb 1, 2021 4:30:12 GMT
Spent the weekend reading up on this one and think it's interesting.
Curent market cap: $70M
float: 3.98M (11.69 o/s)
Debt: none
Fully diluted if warrants and preferred shares converted: approx 37M.
KMPH uses their LAT prodrug technology to improve the attributes of approved drugs in large markets. In particular, ADHD and Stimulant Use Disorder.
I wouldn't have touched this one a few months ago, but since, they did a 1:16 r/s, uploaded to the Nasdaq, eliminated all of their debt, and raised $50M. They have a PDUFA date scheduled for March 2nd. They had no further information requests from the FDA advisory committee after receiving their NDA. It's widely thought that they should win approval. The one point of concern is whether or not they'll receive approval for "30/13" (30 minute onset 13 hour duration) on their label. The data supports that label inclusion but it depends on how the FDA interprets the data.
Even without approval for 30/13, there are still lots of things to like about the potential of the drug. They also have two partners, Gurnet Point Capital who will pay KMPH a $48M milestone payment for FDA approval, and Corium Inc, who will lead all commercialization activities for KMPH's lead candidate KP415.
Here is an easy to understand breakdown by a Reddit poster:
KemPharm is run by the creator of Vyvanse. What he is doing now is applying the same ligand technology to other drugs. Kempharm already has one approved drug, Apadaz, which is a prodrug of hydrocodone. Despite not receiving the abuse deterrent label which was desired, the drug is nonetheless abuse deterrent and also has other advantageous properties, such as decreased incidence of constipation. Currently KVK (Kempharm's commercialization partner for Apadaz) started a program which will gather data on the effectiveness of Apadaz as a substitute for other opioids
www.globenewswire.com/news-release/2020/09/10/2091595/0/en/KemPharm-s-Commercial-Partner-for-APADAZ-KVK-Tech-Enters-into-Collaboration-Agreement-with-Sure-Med-Compliance-Focused-on-Improving-Prescribing-Education-and-Compliance-for-Pain-Th.html.
The main thing everyone is excited about is KP415 (March 2nd PDUFA). Essentially the methylphenidate (ritalin) version of Vyvanse. Investors are fairly confident in approval, however the major risk is that the drug does not receive the desired label (30 minute onset 13 hour duration). Data does, however support these numbers. It's just a matter of how the FDA interprets that data.
Just this week KemPharm also got approval to initiate clinical trials of KP879 for stimulant use disorder. KP879 is the same drug as KP415, however KP415 has an immediate release component (plain methylphenidate) whereas KP879 is just the prodrug. If this gets approval it could be much bigger than KP415. It's essentially suboxone for meth heads.
With recent dilution Kempharm has eliminated debt and has 50M in cash with a 48M milestone payment if KP415 is approved. Additionally, their partner Corium is covering all commercialization expenses for the drug.
Suggest you check out more info and look into data for KP415.
disclosure: long.
---
I don't own any shares yet, but am thinking about it.
Corporate presentation (December 2020 - doesn't include recent financing):
investors.kempharm.com/static-files/c726236f-47e8-4e94-b665-9504441cffc5
CEO letter to shareholders (June 2020):
kempharm.gcs-web.com/static-files/af3b9f16-a8f5-462d-80be-55266dccab75
Curent market cap: $70M
float: 3.98M (11.69 o/s)
Debt: none
Fully diluted if warrants and preferred shares converted: approx 37M.
KMPH uses their LAT prodrug technology to improve the attributes of approved drugs in large markets. In particular, ADHD and Stimulant Use Disorder.
I wouldn't have touched this one a few months ago, but since, they did a 1:16 r/s, uploaded to the Nasdaq, eliminated all of their debt, and raised $50M. They have a PDUFA date scheduled for March 2nd. They had no further information requests from the FDA advisory committee after receiving their NDA. It's widely thought that they should win approval. The one point of concern is whether or not they'll receive approval for "30/13" (30 minute onset 13 hour duration) on their label. The data supports that label inclusion but it depends on how the FDA interprets the data.
Even without approval for 30/13, there are still lots of things to like about the potential of the drug. They also have two partners, Gurnet Point Capital who will pay KMPH a $48M milestone payment for FDA approval, and Corium Inc, who will lead all commercialization activities for KMPH's lead candidate KP415.
Here is an easy to understand breakdown by a Reddit poster:
KemPharm is run by the creator of Vyvanse. What he is doing now is applying the same ligand technology to other drugs. Kempharm already has one approved drug, Apadaz, which is a prodrug of hydrocodone. Despite not receiving the abuse deterrent label which was desired, the drug is nonetheless abuse deterrent and also has other advantageous properties, such as decreased incidence of constipation. Currently KVK (Kempharm's commercialization partner for Apadaz) started a program which will gather data on the effectiveness of Apadaz as a substitute for other opioids
www.globenewswire.com/news-release/2020/09/10/2091595/0/en/KemPharm-s-Commercial-Partner-for-APADAZ-KVK-Tech-Enters-into-Collaboration-Agreement-with-Sure-Med-Compliance-Focused-on-Improving-Prescribing-Education-and-Compliance-for-Pain-Th.html.
The main thing everyone is excited about is KP415 (March 2nd PDUFA). Essentially the methylphenidate (ritalin) version of Vyvanse. Investors are fairly confident in approval, however the major risk is that the drug does not receive the desired label (30 minute onset 13 hour duration). Data does, however support these numbers. It's just a matter of how the FDA interprets that data.
Just this week KemPharm also got approval to initiate clinical trials of KP879 for stimulant use disorder. KP879 is the same drug as KP415, however KP415 has an immediate release component (plain methylphenidate) whereas KP879 is just the prodrug. If this gets approval it could be much bigger than KP415. It's essentially suboxone for meth heads.
With recent dilution Kempharm has eliminated debt and has 50M in cash with a 48M milestone payment if KP415 is approved. Additionally, their partner Corium is covering all commercialization expenses for the drug.
Suggest you check out more info and look into data for KP415.
disclosure: long.
---
I don't own any shares yet, but am thinking about it.
Corporate presentation (December 2020 - doesn't include recent financing):
investors.kempharm.com/static-files/c726236f-47e8-4e94-b665-9504441cffc5
CEO letter to shareholders (June 2020):
kempharm.gcs-web.com/static-files/af3b9f16-a8f5-462d-80be-55266dccab75