Zevra Therapeutics, Inc. · NASDAQ:ZVRA
Zevra Therapeutics — Kempharm — Corporate Update (November 2020)
32 slides from Zevra Therapeutics's corporate update, Nov 23, 2020
Slide 1: Management Presentation
K Pharm Management Presentation
Slide 2: Cautionary Note Regarding Presentation Information
Cautionary Note Regarding Presentation Information This presentation may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended Forward-looking st
Slide 3: KemPharm: Recent Highlights
KemPharm: Recent Highlights KP415 Updates Held mid-cycle review meeting w/ FDA on Aug 13, affirmed PDUFA date of Mar 2, 2021, no safety issues raised at that time - Late-cycle review meeting to be held on Dec 1 Two additional U.S. patents governing SDX products issued, adds 5 years (2037 expiry) Q3
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 Dis with Ligand Prodrugwith Cleaved Drug through Sub-Optimal Improved Attributes Human Metabolic Properties Process 1) Select FDA-approved and widely prescribed drug for improvement,
Slide 5: Partnered Assets — Potential For Near and Long-Term Value
Partnered Assets — Potential For Near and Long-Term Value Meee ER ADHD ieneee ER ADHD rence vse Saore anpreanine ADHD APADAZ® Pain Hydrocodone IR Gurnet Point Capital/Corium Gurnet Point Capital/Corium Gurnet Point Capital/Corium Gurnet Point Capital/Corium KVK Tech Licensed PDUFA Date Mar 2, 2021 A
Slide 6: Current Development Pipeline
Current Development Pipeline product Potential Indication = Parent Drug Next Milestone | Timing of Next A Candidate fj Submission Milestone KP415 a lead PDUFA March 2, 2021 NA ADHD Methylphenidate Initiation of KP484 (ER) Efficacy Trial 2021 2023 Fi ‘Class Therapy Stimulant Use i Disorder Kps7g__| M
Slide 7: KP415 and KP484
KP415 and KP484 D-Methylphenidate Prodrug Products for the Treatment of ADHD
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: KP415 vs. Selected ER Stimulant Products for ADHD
KP415 vs. Selected ER Stimulant Products for ADHD Product KP415 Focalin XR® — Concerta® Features'? Mixed Salts Parent Drug D-MPH D-AMPH of AMPH D-MPH MPH ER Prodrug qi Technology +IR D-MPH ER Prodrug ER MAS ER D-MPH Osmotic Dosage Capsule Capsule & ER ER ER Form 1 Chewable Capsule Capsule Tablet Ons
Slide 11: 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; Corium is leading all commercialization activities Total of up to $493M in upfront and milestone payments; plus royalties on Net Sales Upfront cash — Rec’d $10M, plus
Slide 12: 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 13: Corium, Inc. — An Expanding Relationship
Corium, Inc. — An Expanding Relationship New consultation services agreement between KemPharm and Corium announced on Oct 5, 2020 o Agreement encompasses product development and regulatory activities for certain current and potential future products in Corium’s portfolio o New activities are above a
Slide 14: The Adult ADHD Market
The Adult ADHD Market + Over 4% of U.S. adults, or approximately 10.5 million adults have ADHD and are now the largest part of the ADHD market, comprising 64% of total TRx'2 $ * In 2019, the adult? ADHD market has grown at 5% vs. 1% for the pediatric ADHD market compared to the previous year’ * \Vyv
Slide 15: KP484 Steady State PK vs. Mydayis
KP484 Steady State PK vs. Mydayis’ KP484 vs Mydayis ~ AUC... Normalized KP484 vs Mydayis ~ AUC... Normalized 9 8 —e— KPA84 (steady state) 4 Mydayis (steady state) & & = = 5 5 8 8 § § 3 2 2 1 o o 0 2 4 6 8 1012 4 16 18 20 2 0 2 4 6 8 1012 4 16 18 20 2 Time (hours) Time (hours) Disclaimer: Mydayis ste
Slide 16: KP415 Updates
KP415 Updates * Held KP415 NDA mid-cycle review meeting with FDA on Aug 13, 2020 o FDAre-affirmed KP415 PDUFA date of Mar 2, 2021, no substantive issues or safety concerns were raised o Late-cycle review meeting to be held on Dec 1, 2020 + Corium, Inc. is leading all commercial activities for KP415
Slide 17: KP879: Agonist Replacement Therapy for the Treatment of Stimulant Use Disorder
KP879 Agonist Replacement Therapy for the Treatment of Stimulant Use Disorder (SUD)
Slide 18: 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 19: KP879 for the Treatment of SUD
KP879 for the Treatment of SUD Potential KP879 features and benefits: o Stand-alone formulation of serdexmethylphenidate (SDX) o Releases d-methylphenidate (d-MPH), a dopamine reuptake inhibitor (similar pharmacology as abused stimulants) o Very gradual onset of blood concentrations of released d-MP
Slide 20: KP1077 For the Treatment of Idiopathic Hypersomnia (IH)
KP1077 For the Treatment of Idiopathic Hypersomnia (IH)
Slide 21: Idiopathic Hypersomnia (IH)
Idiopathic Hypersomnia (IH) + There are no approved therapies for IH + Narcolepsy treatments have commonly been used for treating IH symptoms o GHB/sodium oxybate for improved sleep o Stimulants for Excessive Daytime Sleepiness (EDS) = Methylphenidate remains the most commonly used stimulant for IH
Slide 22: KP1077 Product Candidate Overview
KP1077 Product Candidate Overview * Once daily dosing + Potential features and benefits o Single dose allows for symptom control up to 16 hours o Still allows for PRN stimulant use for “break-through” sleepiness * Orphan drug designation potential o Fast-track eligible o Break-through designation el
Slide 23: APADAZ: FDA Approved for the Short-Term Treatment of Acute Pain
APADAZ® FDA Approved for the Short-Term Treatment of Acute Pain
Slide 24: APADAZ Overview
APADAZ® Overview + First FDA-approved prodrug of hydrocodone (benzhydrocodone) combined with acetaminophen with differentiated label and long-lived patents + Licensed to KVK-Tech, Inc. o KemPharm eligible to receive up to $3.4M in initial payments and reimbursements, plus sales milestone payments of
Slide 25: Prodrug Discovery Collaboration
Prodrug Discovery Collaboration
Slide 26: Deerfield and KemPharm Prodrug Discovery Collaboration
Deerfield and KemPharm Prodrug Discovery Collaboration + In connection with our December 2019 debt restructuring, we have agreed to collaborate on a potential prodrug discovery effort with Deerfield + Deerfield, or its affiliates, may identify up to two compounds with applications for new disease in
Slide 27: Financial Update
Financial Update
Slide 28: Q3 2020 Financial Results
Q3 2020 Financial Results + Revenue and Net Income (Loss) o Revenue of $1.9M, comprised of services revenue under the Corium consulting arrangement, compared to Q2 2020 service revenue of $1.9M o Q3 2020 is the fifth sequential quarter of services revenue o Net loss of ($3.0M), or ($0.04) per basic
Slide 29: Q3 2020 Balance Sheet Update
Q3 2020 Balance Sheet Update As of Sep 30, 2020, total cash’ was $5.5M, a decrease of $1.1M compared to Jun 30, 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 Mar 31, 202
Slide 30: Improving Financial Position
Improving Financial Position + Phase 2 of debt restructuring remains one of our highest priorities; goal to complete prior to the KP415 PDUFA date * Continue to work with our financial advisors to determine the best pathway to restructure the debt and optimize the cost of capital/dilution; options i
Slide 31: KemPharm: Next Steps and Outlook
KemPharm: Next Steps and Outlook KP415 NDA FDA has set KP415 PDUFA date of Mar 2, 2021 KP415 Late-Cycle Review meeting with FDA scheduled for Dec 1, 2020 KP415 approval milestones up to $48M KP415 Commercial Progress KemPharm working with Corium on commercial supply for potential 2H 2021 launch Cori
Slide 32: Leveraging our LAT Prodrug Technology to Create Long-Term Value
K Pharm Leveraging our LAT™ Prodrug Technology to Create Long-Term Value For additional information please contact: mmcenroe@tiberend.com