Slide 1: Second Quarter 2017 Results
K Pharm Second Quarter 2017 Results
Slide 2: Cautionary Note Regarding Presentation Information
Cautionary Note Regarding Presentation Information This presentation contains forward-looking statements, including statements about our plans to develop and commercialize our product candidates, our planned clinical trials for our prodrug product candidates, the timing of and our ability to obtain
Slide 3: Second Quarter 2017 — Conference Call Participants
Second Quarter 2017 — Conference Call Participants + Travis Mickle, Ph.D. - President & Chief Executive Officer + R. LaDuane Clifton, CPA - Chief Financial Officer, Secretary & Treasurer * Dan Cohen, M.A.L.S.— EVP, Government & Public Relations
Slide 4: Q2 2017 & Recent Updates
Q2 2017 & Recent Updates Clinical & Regulatory Initiated Development of KP484, A New, Super-Extended Release ADHD Methylphenidate Product Candidate Completed KP415 End-of-Phase 1 Meeting with FDA Presented Clinical Data for KP511 at the International Conference on Opioids Granted First Patent for KP
Slide 5: KemPharm Overview
KemPharm Overview + Specialty pharmaceutical company discovering and developing novel prodrugs + Building a pipeline of prodrug product candidates for the treatment of ADHD, pain and CNS disorders + Leveraging our LAT Platform Technology to improve the attributes of approved drugs in large markets 1
Slide 6: ADHD Prodrug Product Pipeline — Addressing Unmet Needs
ADHD Prodrug Product Pipeline — Addressing Unmet Needs KP415 — ADHD Product Candidate for Fast Onset and Longer Total Duration + Extended release prodrug of d-MPH co-formulated with IR d-MPH + EOP1 meeting with FDA complete; development plan advancing + Positive PK data announced today; + Human abus
Slide 7: ADHD and ER Methylphenidate Market
ADHD and ER Methylphenidate Market * ~$13 billion ADHD market with prescriptions growing at >5% year-over-year * Methylphenidate accounted for approximately 19.8 million TRx’s and $3.8 billion in sales in 2016 « KemPharm believes ADHD key opinion leaders have significant interest in an ER methylphen
Slide 8: ADHD Market Dynamics Support Prodrug Portfolio
ADHD Market Dynamics Support Prodrug Portfolio KP415 In 2016, the branded ADHD market was ~$6.4B and more than 95% of these branded products are extended release’ Prescribers estimate that MPH is given as preferred first line of therapy for children under 13 approximately 60% of the time Prescribers
Slide 9: KemPharm Clinical Product Pipeline
KemPharm Clinical Product Pipeline Potential Product Development Next Catego: Parent Dru: i NDA 9°FY | Candidate HE Status Milestone neeke Submission ADHD Methylphenidate a PK + Efficacy Sa KP415 Clinical 2018 (Pediatric) (ER) Data ADHD Methylphenidate = PK + Efficacy (Adult) KP484 (ER) Clinical bee
Slide 10: Q2 2017 Financial Update
Q2 2017 Financial Update * Q2 2017 net loss of $6.5M, or $0.44 per basic and diluted share, vs. Q2 2016 net income of $9.8M, or basic net income per share of $0.59 and diluted net loss per share of $0.58 Net loss for Q2 2017 was primarily due to loss from operations of $8.2 million and net interest
Slide 11: KemPharm Expected ADHD Milestones
KemPharm Expected ADHD Milestones Product Event KP415 KP415 KP484 KP415/ KP484 2017 KP415 KP484 KP415/ KP484 KP415 2018 KP484 ass | KP484 Report Additional PK Data (2H) v Initiate Pivotal Efficacy Trial (2H) IND Filing (3Q) IV Human Abuse Li ity Data (2H) Pivotal Efficacy Trial Results (1H) Initiate
Slide 12: Second Quarter 2017 Results
K Pharm Second Quarter 2017 Results
Slide 13: Slide 8: KP415 and KP484 Market Data Sources
Slide 8: KP415 and KP484 Market Data Sources 4. Symphony Heath, PHAST 2011-2016 2. Ronald C. Kessler etal. (April2006). The Prevalence and Correlates of Adult ADHD in the United States: Results From the National Comorbidty Survey Replication, American Journal of Psychiatry 163(6):71