Slide 1: Quarterly Update Call — Q4 and FY 2018
K Pharm Quarterly Update Call — Q4 and FY 2018
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: Quarterly Update Call Participants
Quarterly Update Call Participants + Travis Mickle, Ph.D. - President & Chief Executive Officer + R. LaDuane Clifton, CPA - Chief Financial Officer, Secretary & Treasurer + Gordon K. “Rusty” Johnson — Chief Business Officer
Slide 4: KemPharm Leverages its LAT Prodrug Technology to Improve Approved Drugs
KemPharm Leverages its LAT™ Prodrug Technology to Improve the Attributes of Approved Drugs in Large Markets Approved — with Ligand Prodrugwith Cleaved Drug through Sub-Optimal Improved Attributes Human Metabolic Properties Process 1) Select FDA-approved and widely prescribed drug for improvement 2)
Slide 5: Key 2018 Highlights
Key 2018 Highlights KP415 v KP415 pivotal efficacy program completed — July 2018 v KP415 prodrug human abuse potential trials completed — September 2018 APADAZ® v FDA approval — February 2018 v_KVK Tech license agreement — October 2018 LAT™ Value Enhancement v_ twoXAR collaboration — October 2018 v_
Slide 6: Attention-Deficit/Hyperactivity Disorder: KP415 and KP484
Attention-Deficit/Hyperactivity Disorder: KP415 and KP484 for the Treatment of ADHD
Slide 7: KP415 and KP484 Program Overview
KP415 and KP484 Program Overview * Two unique formulations of our prodrug of d-methylphenidate (serdexmethylphenidate, or SDX) addressing unmet needs within the ADHD market + Composition-based patent expires in 2032; pending applications, if granted, may potentially expire in 2037; potentially NCE e
Slide 8: KP415 Clinical Trial Summary
KP415 Clinical Trial Summary + Single, pivotal efficacy trial eo ADHD classroom design o Efficacy trial met its primary endpoint o Secondary endpoints of SKAMP-C, PERMP-A and PERMP-C support 30-minute onset of effect with duration up to 13 hours + SDX human abuse potential (HAP) trials o Statistical
Slide 9: KP415 & KP484 — Key Value Drivers
KP415 & KP484 — Key Value Drivers + NDA submissions o KP415 pre-NDA meeting delayed until Q2 2019 due to government shutdown eo KP415 NDA submission to follow o KP484 NDA planned for 2020 + Strategic Partnering Process o Competitive process in late-stage discussions with a number of potential partne
Slide 10: APADAZ
APADAZ® FDA Approved for the Short-Term Treatment of Acute Pain
Slide 11: APADAZ Product and License Overview
APADAZ® Product and License Overview + First prodrug of hydrocodone (benzhydrocodone) combined with acetaminophen to be approved by the FDA with differentiated properties and long-lived patents + Multiple strengths now approved providing maximum prescribing flexibility: o 4.08 mg benzhydrocodone HCI
Slide 12: APADAZ Launch Update
APADAZ® Launch Update - Accelerate preparation and assistance for anticipated 2H 2019 APADAZ® commercial launch: o Technology and regulatory transfers (NDA) to KVK underway or complete o Manufacturing of commercial supply underway eo Branded APADAZ and authorized generic now on compendia for all thr
Slide 13: LAT: Unlocking Multiple Opportunities to Create Long-Term Value
LAT™ Unlocking Multiple Opportunities to Create Long-Term Value
Slide 14: KemPharm Product Pipeline and Partnered Asset
KemPharm Product Pipeline and Partnered Asset Potential Product Development Next Category Candidate arene DIG) Status Milestone Nee Submission Methylphenidate ini. NDA KP415 (ER) Clinical Submission Q2 2019 ADHD Methylphenidate ini. Initiation of KP484 (ER) Clinical Efficacy Trial 2020 Stimulant 5 U
Slide 15: Stimulant Use Disorder (SUD)
Stimulant Use Disorder (SUD) + Stimulant Use Disorder (SUD) is broadly defined as the abuse or misuse of cocaine, methamphetamine, or other stimulants + Although there are therapies for opioid addiction (buprenorphine, methadone), there are currently no approved treatments for SUD + Studies with ago
Slide 16: KP879 for the Treatment of SUD
KP879 for the Treatment of SUD Potential KP879 features and benefits: eo Stand-alone formulation of serdexmethylphenidate (SDX) o Releases d-methylphenidate, a dopamine reuptake inhibitor (similar pharmacology as abused stimulants) o Very gradual onset of blood concentrations of released d- methylph
Slide 17: KemPharm Prodrug Technology Collaboration with twoXAR
KemPharm Prodrug Technology Collaboration with twoXAR * Technology collaboration to develop prodrug-based therapies for multiple therapeutic areas outside of KemPharm’s product focus and core expertise * Combines KemPharm’s LAT™ technology to potentially create new prodrugs with twoXAR’s artificial
Slide 18: Financial Update
Financial Update
Slide 19: Q4 2018 Financial Results
Q4 2018 Financial Results * Q4 2018 net loss of $5.2M, or $0.20 per basic share, and $0.21 per diluted share, vs. Q4 2017 net loss of $10.6M, or $0.72 per basic and diluted share o Net loss for Q4 2018 primarily due to operating loss of $9.3M and net interest expense and other items of $1.6M, partia
Slide 20: FY 2018 Financial Results
FY 2018 Financial Results « FY 2018 net loss of $56.5M, or $3.15 per basic and diluted share, vs. FY 2017 net loss of $43.4M, or $2.96 per basic and diluted share o Net loss for FY 2018 primarily due to operating loss of $55.9M and net interest expense and other items of $6.5M, partially offset by n
Slide 21: Financial Update
Financial Update + Added financial flexibility to execute on development and partnering strategy: o Completed an underwritten public offering of 8.3M shares in October 2018, receiving net proceeds of approx. $23.1M o Reduced debt by $9.6M via exchange into preferred shares o Entered into a $15M equi
Slide 22: KemPharm Value Proposition
KemPharm Value Proposition KP415/KP484 provide near-term, potentially high value opportunities o Partnership eo NDA submission o Approval o Launch with partner into a large market Building future value o KP879 o Value realization with other assets (i.e. APADAZ, other opioids) o Continue to advance o