Zevra Therapeutics, Inc. · NASDAQ:ZVRA
Zevra Therapeutics — Kempharm — 26th Annual Oppenheimer Healthcare Conference (December 2015)
31 slides from Zevra Therapeutics's conference presentation, Dec 8, 2015
Slide 1: 26th Annual Oppenheimer Healthcare Conference
December 8, 2015 26th Annual Oppenheimer Healthcare Conference Exhibit 99.1
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 KP201/APAP and our other prodrug product candidates, the timing of and o
Slide 3: KemPharm Overview
KemPharm Overview Specialty pharmaceutical company discovering and developing novel prodrugs Leverage LAT Platform Technology to improve the attributes of approved drugs in large markets 505(b)(2) pathway reduces risk and expense Composition-of-matter patent protection KP201/APAP has the potential t
Slide 4: Management Team
Management Team Travis C. Mickle, PhD President and CEO Gordon K. Johnson CBO Tracy M. Woody CCO R. LaDuane Clifton CFO Sven Guenther, PhD EVP of R&D
Slide 5: Ligand Activated Therapy (LAT) Platform Technology
Ligand Activated Therapy (LAT) Platform Technology Select FDA-approved and widely prescribed drug for improvement Chemically modify using a ligand to create a prodrug Ligands – GRAS or demonstrated to be safe Prodrugs generate composition-based patents Following ingestion, normal human metabolic pro
Slide 6: Pipeline of Multiple Product Candidates
Pipeline of Multiple Product Candidates Multiple Other Compounds in Pre-Discovery Stage
Slide 7: Advancing Opioid Abuse-Deterrent Technology
Advancing Opioid Abuse-Deterrent Technology High Tamper Resistance KemPharm’s Molecular Based Abuse-Deterrent Technology Crushing or Physical Manipulation Extraction Chemical Hydrolysis Neutralization and/or Isolation Many Formulation-Based Abuse-Deterrent Opioids Crushing or Physical Manipulation E
Slide 8: Opioid Abuse-Deterrent Landscape
Opioid Abuse-Deterrent Landscape
Slide 9: KP201/APAP Overview
Treatment of Acute Moderate to Moderately Severe Pain KP201/APAP Overview
Slide 10: KP201/APAP Product Features
KP201/APAP Product Features Molecular-Based Abuse-Deterrent Technology Composition-of-Matter Patent Protection Until 2031 No Generic Equivalent Product (Benzhydrocodone) Prodrug composed of hydrocodone and a generally regarded as safe (GRAS) ligand Bioequivalent, No Food Effect, Convenient Dosing Pl
Slide 11: Large Market Opportunity
Large Market Opportunity Hydrocodone is associated with more drug abuse and diversion than any other licit or illicit opioid(1) IR hydrocodone in combination with acetaminophen is the most frequently prescribed opioid in the U.S.(2) IR hydrocodone/APAP products accounted for 127.4 million prescripti
Slide 12: Survey Data Indicates Large Hydrocodone Abuse Problem
Survey Data Indicates Large Hydrocodone Abuse Problem* *Surveyed from January 2012 through September 2014. Total sample included 151,704 adult assessments from 743 centers located in 42 states. Abuse prevalence and patterns for immediate-release hydrocodone combination products. Theresa A. Cassidy,
Slide 13: Age at First IR Hydrocodone Use Among Lifetime Users
Age at First IR Hydrocodone Use Among Lifetime Users* *Survey participants were recruited between December 2014 and March 2015 on Bluelight.org. Patterns of abuse of hydrocodone combination products: Results from an internet survey of recreational drug users. Theresa A. Cassidy, MPH, Natasha K. Oyed
Slide 14: KP201.T01, KP201.T02 and KP201.T03 Tampering Studies
KP201.T01, KP201.T02 and KP201.T03 Tampering Studies KP201/APAP tampering studies designed to evaluate: The potential of extraction of the KP201 prodrug from the tablet formulation and its conversion into active hydrocodone The properties that reduce the likelihood of IV abuse of KP201/APAP The pote
Slide 15: Tampering Studies (cont'd)
KP201.T01, KP201.T02 and KP201.T03 Tampering Studies (cont’d) Greater than 90% of all conditions tested for extraction yielded no hydrocodone released from KP201/APAP Conditions that led to any release of hydrocodone from KP201/APAP required harsh chemicals and usually heat, by comparison, hydrocodo
Slide 16: KP201.A01 Human Abuse Liability Trial
KP201.A01 Human Abuse Liability Trial Oral Human Abuse Liability Trial Compared the drug likability, exposure levels and safety of KP201/APAP compared to Norco after oral administration Single-center, randomized, double-blind, active- and placebo-controlled crossover trial (62 subjects completed the
Slide 17: KP201.A02 Human Abuse Liability Trial
KP201.A02 Human Abuse Liability Trial Intranasal KP201/APAP Human Abuse Liability Trial Assessed the drug likability, exposure levels and safety of KP201/APAP compared to Norco after crushing and intranasal (IN) administration Single-center, randomized, double-blind trial (n=42) Data announced on Oc
Slide 18: KP201.A03 Intranasal PK Trial
KP201.A03 Intranasal PK Trial Intranasal KP201 (API) PK Trial Assesses the drug exposure levels of KP201 (API) compared to hydrocodone bitartrate after intranasal administration Single-center, randomized, double-blind trial (n=24) Data announced on August 13, 2015 36% decrease in peak hydrocodone ex
Slide 19: Summary Trial Results: Abuse Quotient (AQ)
Summary Trial Results: Abuse Quotient (AQ)1 Rank2 Treatment RoA Dose Units (mg) AQ (SD)3 (ng/mL/hrs) 1 KP201 API IN 2 (13.34) 17.0 (11.6) 2 KP201/APAP IN 2 (13.34/650) 31.9 (18.4) 3 HB/APAP PO 2 (15/650) 34.5 (23.3) 4 KP201/APAP PO 2 (13.34/650) 38.6 (21.8) 5 HB/APAP IN 2 (15/650) 56.5 (43.8) 6 HB A
Slide 20: KP201/APAP Commercial Strategy
KP201/APAP Commercial Strategy If approved for marketing, KemPharm has many potential avenues to commercialize KP201/APAP, including but not limited to, a collaboration or establishing a specialist U.S. sales force Potential global / U.S.-based deal targeting large prescriber base, including primary
Slide 21: State Legislative Initiatives
State Legislative Initiatives AL AZ AR CA CO** FL GA ID IL IN IA KS KY LA ME MA MI MN MS MO MT NE NV NH* NM* NY NC ND OH OK OR PA SC SD TN** TX UT** VT VA* WA WV WI WY CT DE MD NJ RI Introduced Passed & signed by Governor, not yet enacted Enacted into law *Bill requires a study of AD inclusion on fo
Slide 22: KP201/APAP Milestones
KP201/APAP Milestones Human Bioequivalence Preclinical Abuse Deterrence / Tamper Resistance Oral Human Abuse Liability Trial Intranasal Human Abuse Liability Trial Intranasal PK Trial Anticipated NDA Submission 4Q 2015 Anticipated NDA Approval (with priority review) As Early as Mid-2016 Anticipated
Slide 23: KP511/ER Overview
Treatment of Moderate to Severe Pain KP511/ER Overview
Slide 24: KP511/ER Product Overview
KP511/ER Product Overview KP511/ER is an ER formulation of KP511, a prodrug of hydromorphone IR bioequivalent release of hydromorphone demonstrated in rats Potential valuable properties based on preclinical data Significantly reduced IN and IV bioavailability (abuse deterrence) Highly tamper resista
Slide 25: KP511/ER Reduced Abuse Potential
KP511/ER Reduced Abuse Potential Intranasal PK Curves Intravenous PK Curves Note: HM refers to hydromorphone hydrochloride. Studies conducted in rats. 2.0 mg/kg (hydromorphone eq.) Average data from 2 studies (N=10) %-AUC = 25% %-Cmax = 22% 0.2 mg/kg (hydromorphone eq.) 1 study (N=5) %-AUC = 5% %-Cm
Slide 26: KP511/ER Potential Oral Overdose Protection
KP511/ER Potential Oral Overdose Protection AUC Note: HM refers to hydromorphone hydrochloride. Studies conducted in rats.
Slide 27: KP415 Overview
Treatment for ADHD KP415 Overview
Slide 28: KP415 Overview
KP415 Overview Prodrug of methylphenidate Branded formulations of methylphenidate (Concerta, Focalin and Ritalin) accounted for sales of $1.1 billion in 2014(1) Potential features and benefits Controlled release methylphenidate Reduced abuse potential Suitable for more patient compliant dosage form
Slide 29: KemPharm Expected News Flow
KemPharm Expected News Flow Product Event Date KP201/APAP NDA Submission 4Q 2015 KP201/IR (APAP-free) IND Filing 2Q 2016 KP201/APAP NDA Approval (Priority Review) As Early as Mid-2016 KP201/APAP DEA Scheduling and Product Launch As Early as 2017 KP511/ER Human POC 2016 KP415 Human POC 2016 KP606/IR
Slide 30: 3Q 2015 Update
3Q 2015 Update Cash and cash equivalents of $59.0 million as of September 30, 2015 A decrease of $5.2 million vs. $64.2 million as of June 30, 2015 3Q 2015 net loss was $9.7 million vs. $7.1 million for 3Q 2014 Increase in net loss year-over-year primarily due to KP201/APAP R&D, increased G&A expens
Slide 31: For additional information please contact
For additional information please contact: Gordon K. “Rusty” Johnson rjohnson@kempharm.com 321-939-3416
Kempharm — 26th Annual Oppenheimer Healthcare Conference (December 2015) on 6ix