Slide 1: Q2 2020 Results
K Pharm Q2 2020 Results
Slide 2: Cautionary Note Regarding Presentation Information
Cautionary Note Regarding Presentation Information This presentation contains forward-looking statements, including statements regarding the potential approval timing for KP415, the potential label for KP415, the royalty or milestone payments under our license agreement with Gurnet Point Capital, th
Slide 3: Q2 2020 Results Call Participants
Q2 2020 Results Call Participants + Travis Mickle, Ph.D. — President & Chief Executive Officer + R. LaDuane Clifton, CPA — Chief Financial Officer, Secretary & Treasurer
Slide 4: KemPharm: Q2 2020 and Recent Highlights
KemPharm: Q2 2020 and Recent Highlights KP415 NDA KP415 NDA accepted by FDA on May 1 - Received $5M milestone payment “Day-74” Letter received - FDA set PDUFA date of Mar 2, 2021 - Advisory committee not anticipated KP415 Commercial & IP Update Corium, Inc., GPC portfolio company, to lead KP415 comm
Slide 5: KP415 Regulatory and Commercial Planning Update
KP415 Regulatory and Commercial Planning Update * KP415 NDA accepted by FDA on May 1, Day-74 Letter received o FDAhas set PDUFA date of March 2, 2021 o Advisory committee not expected to be required © Mid-cycle review meeting with FDA scheduled for tomorrow, August 13" + Announced Corium, Inc., a GP
Slide 6: Summary of KP415/KP484 Partnership Deal Terms
Summary of KP415/KP484 Partnership Deal Terms + Worldwide license with an affiliate of Gurnet Point Capital (GPC) announced Sept 2019; GPC’s portfolio company, Corium, Inc., to lead commercialization + Total of up to $493M in upfront and milestone payments; plus royalties on Net Sales Upfront cash —
Slide 7: Corium, Inc — A GPC Portfolio Company
Corium, Inc —-A GPC Portfolio Company * Commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty pharmaceutical products + Led by Perry Sternberg, President & CEO o 25 years of commercial experience across a wide range of therapeutic areas
Slide 8: ADHD and ER Methylphenidate Market — 2019
ADHD and ER Methylphenidate Market — 2019 + ~$17.5 billion ADHD market with prescription growth of >4% year-over-year + The branded portion of the ADHD market was ~$7.4B in 2019 and more than 95% of these branded prescriptions are for extended release + Methylphenidate (MPH) accounted for approximat
Slide 9: KP415 and KP484 Product Overviews
KP415 KP415 and KP484 Product Overviews KP484 Prodrug of d-MPH (SDX) with extended release properties, co- formulated with IR d-MPH Potential features and benefits: o Once-daily dosing o Earlier onset, long duration o Lower abuse potential o Patient-friendly dosage form Potential to be first MPH pro
Slide 10: Update on APADAZ Commercialization
Update on APADAZ® Commercialization + APADAZ is available nationally for pharmacies to place stocking orders * 23 state Medicaids have added the authorized generic of APADAZ to their preferred drug lists; also added to the Federal Supply Schedule (FSS) + Because the environment for opioids is diffic
Slide 11: Q2 2020 Financial Results
Q2 2020 Financial Results + Revenue and Net Income o Revenue of $6.9M, which includes the $5M KP415 NDA milestone and $1.9M of services revenue compared to Q1 2020 revenue of $2.1M o Q2 2020 is the fourth sequential quarter of services revenue, which is expected to continue o Net income of $0.9 mill
Slide 12: Q2 2020 Balance Sheet Update
Q2 2020 Balance Sheet Update As of June 30, 2020, total cash was $6.6M, an increase of $4.0M compared to March 31, 2020; forecasted cash burn rate of ~$1M/quarter o Based on operating forecast, expected revenues and existing resources, cash runway expected to up to the debt maturity date of March 31
Slide 13: Next Steps on Improving Financial Position
Next Steps on Improving Financial Position + Phase 2 of debt restructuring remains one of our highest priorities; completion prior to the KP415 PDUFA date remains possible + There are several options and complexities for re-positioning the balance sheet; we continue to work with our financial adviso
Slide 14: KemPharm: Next Steps and 2020 Outlook
KemPharm: Next Steps and 2020 Outlook KP415 NDA - PDUFA date for KP415 NDA is set for March | 2, 2021 - NDA “Mid-Cycle Review” scheduled for tomorrow, Aug 13 - Remaining approval milestones up to $58M | Improved Financial Position - Based on current operating forecast, projected cash runway extends
Slide 15: Q2 2020 Results
K Pharm Q2 2020 Results