Zevra Therapeutics, Inc. · NASDAQ:ZVRA
Zevra Therapeutics — Kempharm — Investor Presentation (December 2018)
32 slides from Zevra Therapeutics's investor presentation, Dec 6, 2018
Slide 1: Management Presentation
K Pharm Management Presentation
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: KemPharm Leverages its LAT Prodrug Technology to Improve Attributes of Approved Drugs
KemPharm Leverages its LAT™ Prodrug Technology to Improve the Attributes of Approved Drugs in Large Markets a= Drug 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) Che
Slide 4: KemPharm Product Pipeline
KemPharm Product Pipeline Potential Product Development Next NDA CHEERY Candidate arene DIG) Status Milestone Submission Methylphenidate ay NDA KP415 (ER) Clinical Submission Q1 2019 ADHD Methylphenidat Initiati if jethylphenidate isi nitiation o' KP484 (ER) Clinical Efficacy Trial 2019 Methylphenid
Slide 5: Pursuing Multiple Paths to Create Long-Term Value
Pursuing Multiple Paths to Create Long-Term Value * Leveraging full potential of KemPharm’s LAT™ prodrug technology oe Conventional pharma partnerships for internally developed candidates = KP415 and KP484 partnership opportunities o Joint venture or collaboration with profit sharing = KVK license f
Slide 6: Prodrug New Product Development Partnering
Prodrug New Product Development Partnering + Strategy to potentially leverage KemPharm’s proprietary LAT™ Platform Technology through prodrug technology partnering + Partner benefits may include new or improved products based on potential: o Creation of new, long-lived IP protection eo Modification
Slide 7: KemPharm Prodrug Technology Collaboration with twoXAR
KemPharm Prodrug Technology Collaboration with twoXAR + Technology collaboration announced on October 23, 2018 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 prod
Slide 8: Attention-Deficit/Hyperactivity Disorder: KP415 and KP484 for the Treatment of ADHD
Attention-Deficit/Hyperactivity Disorder: KP415 and KP484 for the Treatment of ADHD
Slide 9: The ADHD and ER Methylphenidate Market
The ADHD and ER Methylphenidate Market + ~$13 billion ADHD market with TRx growth of ~4% per year on average * The branded portion of the ADHD market was ~$6.1B in 2017 and more than 95% of these branded prescriptions are for extended release + Methylphenidate (MPH) accounted for approximately 19.6
Slide 10: Selected ER Stimulant Products for ADHD
Selected ER Stimulant Products for ADHD Brand Name Dosage Reduced Active Ingredient Form (1) Drug Liking (1) + Prodrug of d-amphetamine 10, 20, 30, 40, + Ages: 6 years and older 50,60 &70 + Onset: 1.5 hours a Vyvanse® (lisdexamfetamine) Chewable, ce |e Discos 13 hours Difference + Indicated for bing
Slide 11: Selected ER Stimulant Products for ADHD (Cont'd)
Selected ER Stimulant Products for ADHD (Cont’d) _ 2017 2017 Brand Name 2017 2017 WAG Unk Plan Avg. Patient Active Ingredient TRx’s(1) | Sales(1) See Approval | Out-of-Pocket rice (2) Rate (1) Expense (1) Vyanse® ey 11.6MM $3.38 40mg: $9.02 94% $41.65 Adderall XR® (mixed salts of AMPH) 36MM ‘$805MM
Slide 12: KP415 Product Overview
KP415 Product Overview Prodrug of d-MPH (serdexmethylphenidate, or SDX) with extended release properties, co-formulated with immediate release d-MPH Potential KP415 features and benefits o Once-daily dosing o Earlier onset and longer duration of therapeutic effect o Active metabolism may offer more
Slide 13: KP415.E01 Pivotal Efficacy Trial Summary
KP415.E01 Pivotal Efficacy Trial Summary + KP415.E01 efficacy trial met its primary endpoint * Secondary endpoints of SKAMP-C, PERMP-A and PERMP-C, as measured over time, support a 30-minute onset of effect with duration up to 13 hours + Secondary endpoint of morning and evening behaviors, WREMB-R,
Slide 14: KP415 Prodrug (SDX) Human Abuse Potential Trials
KP415 Prodrug (SDX) Human Abuse Potential Trials Summary + SDX HAP trials were required by FDA to help it determine a recommendation for controlled substance scheduling of the prodrug + Statistically significant differences in key HAP endpoints were observed between SDX and active comparators for al
Slide 15: KP415 Prodrug (SDX) At-the-Moment Drug Liking After Intranasal Administration
KP415 Prodrug (SDX) At-the-Moment Drug Liking After Intranasal Administration vs. D-Methylphenidate At the Moment Drug Liking VAS 90 —=-SDX, 80 mg » —a—d-MPH HCI, 40 mg —s—Placebo 9 Sof Ne Neutral Score tz 2 a 360 a 50 j-#4eeHe--8L-22. 40 0 2 4 8 $ e ° Time (hours) Note: SDX = serdexmethylphenidate
Slide 16: 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 53% of total TRx'2 * The adultADHD market has grown at ~11% per year on average vs. 4% for the pediatric ADHD market for the last several years?
Slide 17: KP484 Product Overview
KP484 Product Overview + Prodrug of d-MPH (serdexmethylphenidate, or SDX) with extended release properties + Potential KP484 features and benefits eo Once-daily dosing o Longer duration than other super-extended release ADHD products o Active metabolism may offer more predictable therapeutic effect
Slide 18: KP484 Steady State PK vs. Mydayis
KP484 Steady State PK vs. Mydayis® KP484 vs Mydayis - AUC. 2, Normalized KP484 vs Mydayis - AUC. 2, 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 s
Slide 19: KP879: Agonist Replacement Therapy for the Treatment of Stimulant Use Disorder
KP879 Agonist Replacement Therapy for the Treatment of Stimulant Use Disorder (SUD)
Slide 20: Stimulant Use Disorder (SUD)
Stimulant Use Disorder (SUD) + Stimulant Use Disorder (SUD) is 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 agonist rep
Slide 21: Stimulant Use Disorder (SUD)
Stimulant Use Disorder (SUD) + Ina 2016 study, approximately 4.3 million Americans over the age of 12 reported stimulant abuse in the last 30 days + Inthe same study, approximately 2.1 million Americans over the age of 12 had SUD (defined as meeting DSM-IV criteria for stimulant abuse or dependence)
Slide 22: KP879 for the Treatment of SUD
KP879 for the Treatment of SUD + KP879 properties: eo Stand-alone formulation of serdexmethylphenidate (SDX) o Releases d-methylphenidate, a dopamine reuptake inhibitor (similar pharmacology as abused stimulant drugs) o Very gradualinitial PK with long release o Low oral, IN, and IV abuse potential
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 prodrug of hydrocodone (benzhydrocodone) combined with acetaminophen to be approved by the FDA + IR fixed-dose combination comprised of 6.67 mg benzhydrocodone HCI (equivalent to 7.5 mg hydrocodone bitartrate) and 325 mg APAP « Apadaz DEA product scheduling and quota allocat
Slide 25: APADAZ Commercial License Agreement with KVK
APADAZ® Commercial License Agreement with KVK As announced on October 30, 2018, KVK is granted the exclusive right for all commercial, manufacturing, packaging and distribution activities for ARADAZ in the U.S. and will be responsible for regulatory and commercialization- related expenses KVK is a p
Slide 26: APADAZ Commercialization Strategy
APADAZ® Commercialization Strategy KVK is expected to continue the same strategy for commercializing APADAZ; approach not expected to require the establishment of a large field sales force N ‘aditional PBM and MCO Partnerships + Pre and post-launch activities include outreach and plan adoption by ph
Slide 27: Financial Update
Financial Update
Slide 28: Q3 2018 Financial Results
Q3 2018 Financial Results * Q3 2018 net loss of $15.1 million, or $0.94 per basic and diluted share, vs. Q3 2017 net loss of $10.0 million, or $0.68 per basic and diluted share o Net loss for Q3 2018 was primarily due to loss from operations of $18.0 million and net interest expense and other items
Slide 29: Conclusion
Conclusion
Slide 30: KemPharm Expected Milestones
KemPharm Expected Milestones Product Event Date KP415/ KP484 IV Human Abuse Potential (HAP) Data Q2 2018 v KP415 Pivotal Efficacy Study Results Mid-2018 v KP415/ KP484 Oral HAP Data 2H 2018 ¥ KP415/ KP484 IN HAP Data 2H 2018 v APADAZ® Secure Commercial Partnership 2H 2018 v KP415/ KP484 Secure Strat
Slide 31: KemPharm's Next Steps
KemPharm’s Next Steps + NDA’s for KP415 and KP484 on track for submission in Q1 2019 and 1H 2020, respectively + Strategic partnering discussions for KP415 and KP484 continue based on: o Significant, near-term ADHD prodrug commercial opportunity o Differentiated onset and duration efficacy profile o
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: jdrumm@tiberend.com