Zevra Therapeutics, Inc. · NASDAQ:ZVRA
Zevra Therapeutics — Kempharm — Q1 2020 Earnings Presentation
15 slides from Zevra Therapeutics's earnings presentation, May 12, 2020
Slide 1: Q1 2020 Results
K Pharm Q1 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: Q1 2020 Results Call Participants
Q1 2020 Results Call Participants + Travis Mickle, Ph.D. - President & Chief Executive Officer + R. LaDuane Clifton, CPA - Chief Financial Officer, Secretary & Treasurer
Slide 4: KemPharm: Recent Highlights
KemPharm: Recent Highlights KP415 NDA | Q1 2020 Financial Results - KP415 NDA accepted by FDA (May 1) |- Revenue of $2.1M, third sequential quarter - $5M milestone payment earned w/ KP415 of development services revenue NDA acceptance |- Net loss of $5.8M, or $0.12 per basic and diluted share - Tota
Slide 5: 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 — $10
Slide 6: 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 7: The ADHD and ER Methylphenidate Market
The ADHD and ER Methylphenidate Market * ~$12.5 billion ADHD market with prescription growth of >4% year-over-year * The branded portion of the ADHD market was ~$6.2B in 2018 and more than 95% of these branded prescriptions are for extended release + Methylphenidate (MPH) accounted for approximately
Slide 8: 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 9: 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 10: Update on APADAZ Commercialization
Update on APADAZ® Commercialization + APADAZ is available nationally for pharmacies to place stocking orders + 19 state Medicaids have added the authorized generic of APADAZ to their preferred drug lists; also added to the Federal Supply Schedule (FSS) + The current environment for opioids is diffic
Slide 11: Q1 2020 Financial Results
Q1 2020 Financial Results + Revenue and Net Loss o Revenue of $2.1M, as compared to Q4 2019 revenue of $1.4M; third sequential quarter of services revenue, which is expected to continue o Net loss of $5.8 million, or $0.12 per basic and diluted share, compared to net loss of $12.3M, or $0.46 per bas
Slide 12: Q1 2020 Balance Sheet Update
Q1 2020 Balance Sheet Update 1 - Includes cash, cash equivalents and restricted cash As of Mar 31, 2020, total cash! was $2.5M, a decrease of $1.1M compared to Dec 31, 2020; forecasted cash burn rate of ~$1M/quarter o Based on operating forecast, expected revenues and existing resources, cash runway
Slide 13: Update on Nasdaq Listing Compliance
Update on Nasdaq Listing Compliance KemPharm has not regained compliance with two of the continued listing requirements for the Nasdaq Capital Market (NCM): o Market value of listed securities (MVLS) continued listing requirement, which is a minimum of $35M, or the o Bid price continued listing requ
Slide 14: KemPharm: Next Steps and 2020 Outlook
KemPharm: Next Steps and 2020 Outlook KP415 NDA PDUFA date for KP415 NDA in March 2021 10-month FDA review from acceptance on May 1, 2020 Remaining approval milestones up to $58M KP415/KP484 Commercial Progress KemPharm working with Corium on commercial supply for potential mid-2021 launch KP415 com
Slide 15: Q1 2020 Results
K Pharm Q1 2020 Results