Slide 1: AZSTARYS FDA Approval
K Pharm AZSTARYS™ FDA Approval Trademarks referenced herein are held by their respective owners
Slide 2: Cautionary Note Regarding Presentation Information
Cautionary Note Regarding Presentation Information This presentation may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended Forward-looking st
Slide 3: AZSTARYS Approval
ASTARYS™ Approval v Announced FDA Approval of AZSTARYS (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, Cll) ANew Once-Daily Treatment for ADHD Consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d- methylphenidate (d-MPH), co-formulated with immediate-release d-MPH C
Slide 4: Sections 1 and 2.3
AZSTARYS™ Label Sections 1 and 2.3 Section 1: Indications and Usage « AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Section 2.3: Administration Information « Administer AZSTARYS orally once daily in the morning with o
Slide 5: Section 6.1: Clinical Trials Experience
AZSTARYS™ Label Section 6.1: Clinical Trials Experience To adjust for normal growth, z-scores were derived (measured in standard deviations [SD]); z- scores normalize for the natural growth of children and adolescents by comparisons to age- and sex-matched population standards. A z-score change less
Slide 6: Section 12.3: Pharmacokinetics
AZSTARYS™ Label Section 12.3: Pharmacokinetics ¢ Noclinically meaningful differences in the exposure of dexmethylphenidate were observed when administered after an overnight fast, with a high-fat, high-caloric meal, or sprinkled onto applesauce or water. The median time to peak plasma concentration
Slide 7: Figure 2: LS Mean Change in SKAMP-Combined Score
AZSTARYS™ Label Figure 2: LS Mean Change in SKAMP-Combined Score from Baseline after Treatment with AZSTARYS or Placebo during Classroom Day in Pediatric Patients (6 to 12 years) with ADHD LS Mean SKAMP.Combined Change from Baseline A 12 1D AZSTARYS: 00st 2 4 8 10 2 13 Time (hours) IMPORTANT SAFETY
Slide 8: Partnership with Gurnet Point Capital and Corium, Inc.
Partnership with Gurnet Point Capital and Corium, Inc. + Worldwide license with an affiliate of Gurnet Point Capital (GPC) announced Sept 2019 o Corium, a GPC portfolio company, is leading all commercialization activities « License agreement includes a total of up to $483 million in upfront and mile
Slide 9: KemPharm: Next Steps and Outlook
KemPharm: Next Steps and Outlook AZSTARYS™ - FDAhas approved AZSTARYS NDA - KP415 eligible to receive up to $468 million in regulatory and sales milestone payments - Tiered royalties as a percentage of U.S. net sales ranging from the high-single digits to mid-twenties AZSTARYS Commercial Progress -
Slide 10: AZSTARYS FDA Approval
K Pharm AZSTARYS™ FDA Approval