Slide 1: Third Quarter 2017 Results
K Pharm Third 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 obtai
Slide 3: Third Quarter 2017 — Conference Call Participants
Third 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 8 ee
Slide 4: Q3 2017 & Recent Updates
Q3 2017 & Recent Updates Development and Regulatory Filed IND for KP484, a Super-Extended Release ADHD Methylphenidate Prodrug Product Candidate Announced FDRR Process Completion and Resubmission of the Apadaz™ NDA o FDA Has Assigned a PDUFA Action Date of February 23, 2018 Entered into Licensing an
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
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 product candidate + Prodrug of d-MPH co-formulated with IR d-MPH + Positive PK data announced Q2 + Pivotal efficacy trial expected to begin in 2H 2017; da
Slide 7: ADHD Market Dynamics Support Prodrug Portfolio
ADHD Market Dynamics Support Prodrug Portfolio KP484 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 Presc
Slide 8: LAT Strategy
LAT™ Strategy + Harness our proprietary LAT™ Platform Technology by partnering with other companies that could benefit from KemPharm's prodrug discovery and development capabilities + Partner benefits could include new products, product improvements and/or life-cycle extension opportunities base on
Slide 9: Apadaz — FDRR Completion & NDA Resubmission Timeline
Apadaz —- FDRR Completion & NDA Resubmission Timeline Product Overview IR opioid fixed-dose combination product comprised of 6.67 mg benzhydrocodone HCI (a prodrug of hydrocodone equivalent to 7.5 mg hydrocodone bitartrate) and 325 mg APAP Molecular-based abuse-deterrent technology Potential valuabl
Slide 10: KemPharm Product Candidates
KemPharm Product Candidates Potential NDA. Product Parent Drug Development Status Next Milestone KP415 Methylphenidate (ER) Clinical PK + Efficacy Data 2018 KP484 Methylphenidate (ER) Clinical PK + Efficacy Data 2019 TBD (Genco) TED Discovery Candidate Selection TED Apadaz™ Hydrocodone/APAP NDAResub
Slide 11: Financial Update - Q3 2017 Results
Financial Update - Q3 2017 Results + Q3 2017 net loss of $10.0M, or $0.68 per basic and diluted share, vs. Q3 2016 net loss of $13.4M, or $0.92 per basic and diluted share Net loss for Q3 2017 was primarily due to loss from operations of $9.6 million and net interest expense and other items of $1.7
Slide 12: KemPharm Expected Milestones
KemPharm Expected Milestones Product Event 2017 2018 2019 Apadaz KP484 KP415 KP415/KP484 Apadaz KP415 KP4s4 KP415/KP484 KP415 KP484 KP484 FDRR Resolution and NDA Resubmission v IND Filing (3) v Initiate Pivotal Efficacy Trial (2H) IV Human Abuse Liability (HAL) Data PDUFA Date - 02/23/2018 Pivotal E
Slide 13: Third Quarter 2017 Results
K Pharm Third Quarter 2017 Results
Slide 14: Market Data Sources
Slide 7: KP415 and KP484 Market Data Sources 1 Symphony Heath, HAST 2011-2016 2. Rana © Keasleretal (Apr2008) he Prevalence and Corres of Agut ADHD the Untad States: Resuts From the National Comorbidty Survey Repeston, American Journal of Psychiatry 163)