Slide 1: Q2 2018 Results
K Pharm Q2 2018 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: Q2 2018 Results Call Participants
Q2 2018 Results 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: KemPharm Product Pipeline
KemPharm Product Pipeline Potential Product Development Next category Candidate TOHELINT Status Milestone ne Submission Methylphenidate a Oraland IN KP415 (ER) Clinical HAP Data Q1 2019 ADHD Methylphenidate ti if jethylphenidate ini jation of KP484 (ER) Clinical Efficacy Trial 2019 | Potential Apada
Slide 5: Recent Clinical Development Highlights
Recent Clinical Development Highlights * On July 9, announced top line results from the KP415.E01 efficacy and safety trial in children with ADHD * On May 10, announced topline results from the KP415.A03 Intravenous Human Abuse Potential trial of the KP415 prodrug
Slide 6: KP415 Product Overview
KP415 Product Overview + Prodrug of d-MPH (serdexmethylphenidate) with extended release properties, co-formulated with immediate release d-MPH + Potential KP415 features and benefits eo Once-daily dosing o Earlier onset and longer duration of therapeutic effect o Active metabolism may offer more pre
Slide 7: KP415.E01 Efficacy Trial Overview
KP415.E01 Efficacy Trial Overview + First patient treatment occurred on December 20, 2017 * Double-blind, placebo-controlled, randomized, parallel, analog classroom trial * Children 6 to 12 years with ADHD (150 completers) + 5U.S. trial sites, 2-3 cohorts each; 5-18 subjects per cohort/per site + 3-
Slide 8: KP415.E01 Efficacy Trial Met its Primary Endpoint
KP415.E01 Efficacy Trial Met it’s Primary Endpoint + KP415.E01 met the primary endpoint of mean difference in change from baseline (pre-dose Visit 5) across all post-dose time points for the SKAMP- C score (p<0.001) Changein SKAMP-C from Pre-dose Visit 5 Difference in 95% Confidence eS Items) LS mea
Slide 9: Differences in SKAMP-C Change Between KP415 and Placebo
Differences in SKAMP-C Change Between KP415 and Placebo Were Statistically Significant Baseline = predose (prespecified)" (post hoc)" Difference in Difference in LS mean (SE) LS mean (SE) Time KP415— Placebo p-Value KP415— Placebo _p-Value Predose 2.37 (1.18) 0.044 0.60 (1.14) 0.600 O.5hours postdos
Slide 10: Differences in PERMP-A Change Between KP415 and Placebo
Differences in PERMP-A Change Between KP415 and Placebo Were Statistically Significant Baseline = predose (prespecified)" (post hoc)" Difference in Difference in LS mean (SE) LS mean (SE) Time KP415— Placebo p-Value KP415— Placebo _p-Value Predose -0.43 (5.18) 0.933, 0.26 (4.40) 0.953 O.5hours postd
Slide 11: Differences in PERMP-C Change Between KP415 and Placebo
Differences in PERMP-C Change Between KP415 and Placebo Were Statistically Significant Baseline = predose (prespecified)" (post hoc)" Difference in Difference in LS mean (SE) LS mean (SE) Time KP415— Placebo p-Value KP415— Placebo _p-Value Predose -0.97 (5.12) 0.850 0.07 (4.27) 0.986 O.5 hours postd
Slide 12: KP415.E01 Efficacy Trial Summary
KP415.E01 Efficacy Trial Summary + KP415.E01 efficacy trial met its primary endpoint + SKAMP-C trial data using Visit 6 as the pre-dose baseline demonstrate a 30-minute onset of effect with duration up to 13 hours *« PERMP-A and PERMP-C trial data are also supportive of a 30-minute onset of effect w
Slide 13: Drug Liking VAS After IV Injection of KP415 Prodrug was Similar to Placebo
Drug Liking VAS After IV Injection of KP415 Prodrug was Similar to Placebo At the Moment Drug Liking VAS Scores —*-KP415 Prodrug —e-d-MPH HCI —e-Placebo VAS Score Time (hours) Note: d-MPH HCI = dexmethylphenidate hydrochloride Drug Liking was assessed on a bipolar scale (0 = Strong Disliking, 50 = N
Slide 14: Next Steps
Next Steps + KP415 NDA remains on track for submission in Q1 2019 *« KP484 NDA submission expected to follow later in 2019 + Strategic partnering discussions for KP415 continue based on: o Significant, near-term ADHD prodrug commercial opportunity o Differentiated onset and duration efficacy profile
Slide 15: Q2 2018 Financial Results
Q2 2018 Financial Results * Q2 2018 net loss of $10.0 million, or $0.65 per basic share and $0.91 per diluted share, vs. Q2 2017 net loss of $6.5 million, or $0.44 per basic and diluted share o Net loss for Q2 2018 was primarily due to loss from operations of $13.9 million and net interest expense a
Slide 16: KemPharm Expected Milestones
KemPharm Expected Milestones Product Event Date KP484 IND Filing 2017 v KP415 Initiate Pivotal Efficacy Study 2017 v Apadaz® FDA Approval 02/23/18 v KP415/ KP484 IV Human Abuse Potential (HAP) Data Q2 2018 v KP415 Pivotal Efficacy Study Results Mid-2018 ¥ KP415/ KP484 Oral HAP Data 2H 2018 KP415/ KP
Slide 17: Q2 2018 Results
K Pharm Q2 2018 Results