Zevra Therapeutics, Inc. · NASDAQ:ZVRA
Zevra Therapeutics — Kempharm — Investor Presentation (March 2018)
34 slides from Zevra Therapeutics's investor presentation, Mar 12, 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 ur ability to obtain a
Slide 3: KemPharm Overview
KemPharm Overview + Specialty pharmaceutical company discovering and developing novel prodrugs + Leveraging our LAT™ Platform Technology to improve the attributes of approved drugs in large markets + Building a pipeline of product candidates for ADHD, pain and CNS disorders + Potentially utilizing F
Slide 4: LAT (Ligand Activated Therapy) Platform Technology
LAT™ (Ligand Activated Therapy) Platform Technology Approved Drug with Ligand Prodmugwith Cleaved Drug through ‘Sub-Optimal Improved Attributes Human Metabolic Properties Process 1) Select FDA-approved and widely prescribed drug for improvement 2) Chemically modify using a ligand to create a prodrug
Slide 5: KemPharm Near-Term Product Pipeline
KemPharm Near-Term Product Pipeline Potential Product Development| _ Next Category | Candidate | Parent Prug Status Milestone ee Submission Methylphenidate PK + Efficacy KP415 Hal Clinical ome 12019 ADHD Methylphenidate , PK + Efficacy Kp4s4 Hat Clinical me 2019 | Hydrocodone/ Commercial a Apadaz re
Slide 6: Prodrug New Product Development Partnering
Prodrug New Product Development Partnering + Strategy to potentially leverage KemPharm’s proprietary LAT™ Platform Technology through partnering + Partner benefits may include new or improved products based on potential: o Creation of new, long-lived IP protection o Modification of pharmacokinetic p
Slide 7: Attention-Deficit/Hyperactivity Disorder: KP415 and KP484
Attention-Deficit/Hyperactivity Disorder: KP415 and KP484 For the Treatment of ADHD
Slide 8: ADHD and ER Methylphenidate Market
ADHD and ER Methylphenidate Market * ~$13 billion ADHD market with prescriptions growing at >5% year-over-year + Methylphenidate accounted for approximately 19.8 million TRx’s and $3.8 billion in sales in 2016 + KemPharm believes ADHD key opinion leaders have significant interest in an ER methylphen
Slide 9: KP415: ADHD Market Dynamics
KP415: ADHD Market Dynamics + In 2016, the branded ADHD market was ~$6.4B and more than 95% of these branded products are extended release’ + ADHD market has become more genericized, but many generics are priced closely to their branded comparator + Recent ADHD new product launches have been based o
Slide 10: KP415 Product Overview
KP415 Product Overview + Prodrug of d-methylphenidate (MPH) with extended release properties, co- formulated with immediate release d-methylphenidate + Potential KP415 features and benefits o Early onset of action o Potential longer total duration than current MPH therapies o Active metabolism may o
Slide 11: KP415 Single and Multiple Oral Dose PK
KP415 Single and Multiple Oral Dose PK Anticipated KP415 Commercial Formulation Anticipated KP415 Commercial Formulation Single Dose PK Steady State PK ca ca 20 20 = = Ps —eK815,12/56mg* Bas eK a15, 12/55 me* 4 4 z z = 10 = 10 é é 5 3 0 2 4 6 8 102 16 16 18 2 2 2 4 6 8 10 12 14 16 18 20 2 2% ‘Time (
Slide 12: KP415 Steady State PK vs. Focalin XR
KP415 Steady State PK at 13 Hours vs. Focalin XR Anticipated KP415 Commercial Formulation Focalin XR, 40 mg Steady State PK Steady State PK 25 aes —*-KP415, 12/56 mg (steady state)* 25 —*-Focalin XR, 40 mg (steady state) z 3 if = $20 2 gs 3 q Es : : $n : : Prem @ 13hours ix gs SSna/m. @ 2hours 5 of
Slide 13: KP415 Steady State PK vs. Vyvanse
KP415 Steady State PK vs. Vyvanse’ Anticipated KP415 Commercial Formulation Vyanse, 70mg Steady State PK Steady State PK 5 %0 ze ge —=Kpa15,12/56mg* B79 a Wane 208 3 Fo Eas e i H H 840 § 10 : 3 f= 5 z 3 $20 g 310 of of 0 2 4 6 8 10 2 14 16 1B 20 2 2 0 2 4 6 8 10 2 14 16 1B 20 2 2 ‘Time (hours) ‘Time
Slide 14: KP484: Adult ADHD Market Dynamics
KP484: Adult ADHD Market Dynamics + Over 4% of U.S. adults, or approximately 10.5 million adults have ADHD* + If approved, KP484 would launch into the high growth adultADHD market o The adultADHD market has grown at 11% YoY vs. 4% for the pediatric ADHD market for the last several years! o Adults ar
Slide 15: KP484 Product Overview
KP484 Product Overview + Prodrug of d-methylphenidate with extended release properties + Potential KP484 features and benefits o True once-daily dosing o Potentially longer duration than other super-extended release ADHD products o Active metabolism may offer more predictable therapeutic effect o Lo
Slide 16: KP484 Single and Predicted Multiple Oral Dose PK
KP484 gle and Predicted Multiple Oral Dose PK KP484- Oral PK, Single Dose KP484— Predicted Oral PK, Steady State KP484, 60 mg, KP484, 60 mg a 8 2 Kass, 60 me = KPA84, 60 mg, age 2 z zr 5 4 ee 3° BS z z gs Ee é 83 z2 = z 32 a a ° o+ o 4 8 2 6 mM 2w o 4 8 2 6 mM 2w Time (hours) Time hours) Note: Stead
Slide 17: KP484 Steady State PK vs. Mydayis
KP484 Steady State PK vs. Mydayis* KP484 vs Mydayis ~ AUC... Normalized KP484.vs Mydayis - AUC... Normalized + Mydayis (steady state) = KPaas (steady state) LZ 6 g g 5 gS g g ; &: & : : : i (thituediadeas “lhiiiddddecd ‘Time (hours) ‘Time (hours) Disclaimer: Mydayis steady-state plasma concentration
Slide 18: Data Indicates KP484 May Have No Food Effect
Data Indicates KP484 May Have No Food Effect —2-KP484, 60 mg, fasted —#-KP484, 60mg, fed Concentration (ng/mL) 0 4 8 2 16 20 24 28 32 36 Time (hours) Note: Subjacts in the fad treatment arm received a single dose of KP484, 60 mg within 20 minutes following a standardized breakfast | Se
Slide 19: KP415 Clinical Update and Development Timeline
KP415 Clinical Update and Development Timeline + Announced completion of End-of-Phase 1 Meeting on June 28, 2017 + Announced completion of End-of-Phase 2 Meeting on November 16, 2017 + FDA raised no objections to proposed KP415 clinical program o Single efficacy study + Data from multiple PK studies
Slide 20: KP484 Clinical Update and Development Timeline
KP484 Clinical Update and Development Timeline * KP484 IND filing announced on September 20, 2017, but clinical program already initiated under KP415’s IND + KP484 and KP415 are each expected to benefit from each other's development program, with KP484/KP415 clinical studies completed to date includ
Slide 21: Apadaz: FDA Approved for the Short-Term Treatment of Acute Pain
Apadaz™ FDA Approved for the Short-Term Treatment of Acute Pain
Slide 22: Apadaz FDA Approval
Apadaz™ FDA Approval First prodrug of hydrocodone combined with acetaminophen to be approved by the FDA + Indicated for the short-term management of acute pain severe enough to require an opioid analgesic + Apadaz DEA product scheduling and quota allocation is complete + Provides opportunity to intr
Slide 23: Apadaz Product Overview
Apadaz™ Product Overview + IR fixed-dose combination comprised of 6.67 mg benzhydrocodone HCI (equivalent to 7.5 mg hydrocodone bitartrate) and 325 mg APAP + Benzhydrocodone prodrug consists of hydrocodone plus benzoic acid + Absent of “abuse-deterrent” claims, differentiated properties based on Apa
Slide 24: Differences Observed in Drug Liking, Feeling High and Take Drug Again
Differences Observed in Drug Liking, Feeling High and Take Drug Again of IN and Oral Apadaz vs. Norco (Study A02) LS Mean Parameter INNorco _—_ Oral Norco Drug Liking Emax 79.0 77.9 0.6881 Feeling High E,,a. 59.0 60.3) 0.8049 Take Drug Again 74.5 74.0 0.6835 LS Mean $$$ IN vs. Oral Parameter IN Apad
Slide 25: Oral and IN Drug Liking of Apadaz vs. Norco (Study A02)
Oral and IN Drug Liking of Apadaz™ vs. Norco (Study A02)! Norco Drug Liking: Oral vs Intranasal ‘Apadaz Drug Liking: Oral vs Intranasal 100 my eee res i asia a fo eu | g E. ae de Fo Neutral Liking i js : S oe ot ma ‘Time (hours) ‘Time (hours) Based on the overall results, APADAZ cannot be expected t
Slide 26: Apadaz Label — Key Areas of Differentiation
Apadaz™ Label — Key Areas of Differentiation Section 2 (Dosage and Administration) APADAZ: Initiate treatment with APADAZ at 1 to 2 tablets every 4 to 6 hours as needed for pain. Dosage should not exceed 12 tablets in a 24-hour period Norco: The usual adult dosage is 1 tablet every 4 to 6 hours as n
Slide 27: Apadaz Label — Key Areas of Differentiation (cont'd)
Apadaz™ Label — Key Areas of Differentiation (cont’d) Section 9.2 (Abuse) Intranasal Clinical Abuse Potential Study * Over the first 2 hours post-dosing (AUCy.95, AUCy),, and AUC, »), the cumulative hydrocodone exposure was lower following intranasal APADAZ compared to intranasal hydrocodone/acetami
Slide 28: Apadaz Label — Key Areas of Differentiation (cont'd)
Apadaz™ Label — Key Areas of Differentiation (cont’d) Section 9.2 (Abuse) (cont'd) In Vitro Testing + The efficiency of extracting benzhydrocodone from APADAZ was similar compared to the efficiency of extracting hydrocodone from the non-abuse- deterrent hydrocodone/acetaminophen control. Further con
Slide 29: Apadaz Label — Key Areas of Differentiation (cont'd)
Apadaz™ Label — Key Areas of Differentiation (cont’d) 100 Count Bottle Blister Pack Rx Only NDC 70040-0167-3 APADAZ™ € (benzhydrocodone and acetaminophen) 6.12 mg / 325 mg aisles ye Lor 245 Lbs Tar mirny SN 1234567890 TIN 1254567890
Slide 30: Apadaz Commercialization Strategy
Apadaz™ Commercialization Strategy KemPharm is pursuing two potential strategies for commercializing Apadaz. Neither strategy requires KemPharm to establish its own sales force. Pharma Partnership + Collaborative partnerships with + Partnership with a US-based or leading US PBMs who would global gen
Slide 31: KemPharm Expected Milestones
KemPharm Expected Milestones Product Event Date KP484 IND Filing 2017 v KP415 Initiate Pivotal Efficacy Study 2017 v Apadaz™ FDA Approval 02/2318 v KP415/ KP484 IV Human Abuse Liability (HAL) Data 2018 KP415 Pivotal Efficacy Study Results 2018 KP484 Initiate Pivotal Efficacy Study 2018 KP415/ KP484
Slide 32: Q3 2017 Financial Update
Q3 2017 Financial Update + Total cash! of $55.6 million as of September 30, 2017 o Used $10.2 million of cash during Q3 2017 * Q3 2017 net loss of $10.0 million, or $0.68 per basic and diluted share vs. Q3 2016 net loss of $13.4 million, or $0.92 per basic and diluted share © Net loss for Q3 2017 wa
Slide 33: For additional information please contact
K Pharm For additional information please contact: jdrumm@tiberend.com
Slide 34: KP415 and KP484 Market Data Sources
Slides 9 and 14: KP415 and KP484 Market Data Sources 1. Symphony Heath, PHAST 2011-2016 2. Ronald €. Kessa etal. (Apri2008).The Prevalence and Correlates of Adut ADHD nthe United Sates: Resuts From the National Comerbity Survey Replcaton, ‘mean Journal of Payenatry 1625)71