KemPharm Issues Letter to Shareholders - Seite 2

Working with our existing debtholders, led by Deerfield Management (“Deerfield”), we were also able to complete an initial restructuring of our outstanding debt in December 2019, which allowed us to extend all principal and interest payments to a new maturity date of March 31, 2021, which is past the PDUFA date for KP415.  This has extended our cash runway and allows us to capitalize on the opportunities that arise from the KP415/KP484 License Agreement and the potential approval of KP415 to negotiate a long-term restructure of our balance sheet. 

Based on these recent events and accomplishments, we are very optimistic about KemPharm’s short- and long-term prospects.   This enthusiasm is rooted in three core beliefs:

1) KP415, if approved, has the potential to reshape the ADHD treatment landscape, particularly the methylphenidate product market;

2) Corium possesses the most well-suited and experienced commercial organization to launch and maximize the potential market for KP415; and

3) Addressing KemPharm’s debt is an achievable goal.

The ADHD Market Opportunity – KP415 and KP484

The ADHD market accounts for approximately $17.9 billion of revenue in 2019 with a year-over-year prescription growth rate greater than four percent (4%).  Within this, the branded portion of the ADHD market was approximately $7.4 billion in 2019, with extended release products representing more than 97% of the branded prescriptions.  

In 2019, the methylphenidate (MPH) portion of the ADHD market accounted for approximately 20 million prescriptions and $4.9 billion in sales.  Over the last several years, Jornay PM (marketed by Ironshore Pharmaceuticals, Inc.) is the only new MPH product that has been introduced to the market.  However, our research suggests that prescribers and patients remain eager for truly innovative new treatment options.  KP415 is based on serdexmethylphenidate (“SDX”), which is KemPharm’s prodrug of d-methylphenidate, which, if approved, would be the first prodrug of methylphenidate made available to the ADHD market.

KemPharm designed both KP415 and KP484 to specifically target several key unmet needs with the most widely prescribed MPH treatments for ADHD. With respect to KP415, its target design attributes include improving onset of action, providing consistent therapy with a longer duration, and reducing abuse potential.  Based on the data obtained from KP415’s clinical program, we believe these design goals have been met.  Now, we are collaborating with Corium to support the NDA review process which will determine the final label for KP415, and, if approved, to bring these potential benefits to the ADHD market.