Zevra Therapeutics, Inc. · NASDAQ:ZVRA
Zevra Therapeutics — Kempharm — Canaccord Genuity 36th Annual Growth Conference (August 2016)
28 slides from Zevra Therapeutics's conference presentation, Aug 11, 2016
Slide 1: Canaccord Genuity 36th Annual Growth Conference
K Pharm Canaccord Genuity 36th Annual Growth Conference
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 out product candidates, our planned lirica tals for our prodrug product candidates, the timing of and regulatory approvals for o
Slide 3: KemPharm Overview
KemPharm Overview pecialty p prodrugs Leverage LAT Discovery F drugs in large markets ADHD and CNS
Slide 4: Ligand Activated Therapy (LAT) Discovery Platform
Ligand Activated Therapy (LAT) Discovery Platform —> ‘Approved Drug with Ligand Prodrug with Cleaves Drug through ‘Sub-Optimal Improved Attributes de -« Properties 1) Select FDA ly improvement 2) Chemically y > Ligand o Pl based F : ig and release the active drug + Proprietary to KemF i licabl
Slide 5: Advancing Opioid Abuse-Deterrent Technology
Advancing Opioid Abuse-Deterrent Technology Many Formula Crushing or Physical Based Abuse-Deterrent Baloretys a Manipulator KemPharm’ rushing or Physi cael Technology Manipul Ayerolyels
Slide 6: Recent Clinical Development & Regulatory Highlights
Recent Clinical Development & Regulatory Highlights p iew meeting with FDA for Apadaz Ie} p Response Letter (CRL) . 11 Phase 1 Proof-of-Concept Trial . 11 hi b end . pl y reg y Ie} DA for KP415 and KP201/IF [~—«T PAD
Slide 7: End of Review Meeting with FDA
End of Review Meeting with FDA + Primary goals for the End of Revi ing gain g clarity into path forward for i bi d claims > Hydrocod ‘Oph, binati di b i i i j | IR ° prescription opioid market o F . i ion “blister” it which o Blister p Chronic Pain Tas
Slide 8: Product Pipeline
Product Pipeline Product . Parent Dru: ity] Phase1 | Phase3 | NDA Next Milestone Candidate Apadaz™ Hydrocodone i KP511/ER | Hydromorphone PAIN KP201/1R Hydrocodone KP60E/IR Oxycodone Development Preclinical KP746 ‘Oxymorphone Dovolopment ADHD KP415 Metnyeaate IND Submission CNS KP303 Quetiapine Prec
Slide 9: KP201/IR (APAP-free) Overview
KP201/IR (APAP-free) Overview Short-Term Treatment of Acute Pain Tay
Slide 10: KP201/IR (APAP-free) Product Overview
KP201/IR (APAP-free) Product Overview °F ially lated i in the U.S. An abi bl y to Vicodin, Norco and Lortab, but with f havi dded APAP , he ED. PAP h f g DA, drug-related liver injury o In 2011, the FDA limi prescription products . Ab’ Det it Technology + No generic equivalent product fc - . p : NDA
Slide 11: Intranasal Abuse of Apadaz Prodrug Demonstrated Lower Exposure
Intranasal al of Apadaz Prodrug Demonstrated ower HC Re 40 -e-Hydrocodone, Intranasal y J so} ff ; t Mean + SE 20 t Hydrocodone t Concentration Hi (ng/mL) t / ! t q o te 0 1 2 3 4 Time (hours) Study A03: Intranasal HAP Study of APIs 1 [~—«T PAD
Slide 12: Drug Liking Over Time Mirrored PK Findings
in Stu’ Mean Drug Liking [~—«T PAD oe in Drug Liking Over Time Mirrored PK Findings 03 -@-Hydrocodone, Intranasal 100 5 -# Apadaz Prodrug, Intranasal 90 4 60 4 50 2 3 4 Time (hours) ‘Study A03: Intranasal HAP Study of APIs iP
Slide 13: KP511/ER Overview
KP511/ER Overview Treatment of Severe Pain NN Ee ns
Slide 14: KP511/ER Product Overview
KP511/ER Product Overview KP511/ER i i fF KP511 tential cantly o Highly tamper resistant ° - Co iti p
Slide 15: Hydromorphone ER Market
Hydromorphone ER Market * Hydromorphone prescribers: ~3,500 branded prescribers o ~140,000 generic prescribers Th 509 J ntion bh ° Primarily Pain, Anesthesiology and Rehab + Exalgo, th y ER d th, AD labeli [~—«T PAD
Slide 16: Clinical Study KP511.101 — Oral PK in Humans
Clinical Study KP511.101 — Oral PK in Humans ——KP511, 8 mg Dilaudid Oral Liquid, 4 mg a HM Concentration (ng/mL) “~ ~ 5 2 Time (hours) Note: Dilaudid Oral Liquid is an oral solution of hydromorphone yeroctionie at a concantaton of 1 mg/mL. KP511, 8 mg is the molar equivalent of Dilaudid Oral Liquid,
Slide 17: KP511/ER Reduced Abuse Potential
KP511/ER Reduced Abuse Potential Intranasal PK Curves Intravenous PK Curves 1,200 8 8 Hydromorphone Concentration {agit} 8 8 HM (compiled) 60 14 (com > KP 511 Z 0 § 40 Hy 2 20 8 5 2 2 & § z £0 z °. ° 0s 4 15 nm th £0 maglkg(hycromorphor = 22 mao yeronemone en) ea) . “oe cast trom? sudes (N=10) . nen
Slide 18: KP511/ER Potential Oral Overdose Protection
KP511/ER Potential Oral Overdose Protection 3.500 aoe HM-HC! extrapolated 8.000 eS HHI (HM) 5 — e511 (HM) = 2500 3 & E 2,000 g 2 1500 1,000 500 . . 4 8 12 16 2 24 28 32 96 40 44 48 52 56 60 Dose [mg/kg HM] HM refers to hydromorphone hydrochloride. Studies conducted in rats.
Slide 19: KP511/ER Clinical Update
KP511/ER Clinical Update * IND AcbI the F March 201 . P Phase 1 pi June 26, 2016 é parable hyd hy p bety 4mg id™ Oral Liquid q mg d f KP511 .F h buse liability (HAL di per and p and the | to li | ab d/or overdose o | p y year-end 2016 Iso i d to ii i imp reduce opioid- induced constipation (OIC) Tas
Slide 20: KP415 Overview
KP415 Overview Treatment for ADHD 1 OS UU
Slide 21: KP415 Product Overview
KP415 Product Overview + Prodrug of methylphenidate + Potential features and benefits ° times longer three o Reduced abuse potential o Suitable for = Highly water soluble bI * Oral thin film, orally dissolving tablet, liquid, chewable ae p NCE eligible 1TaSy
Slide 22: ADHD and ER Methylphenidate Market
ADHD and ER Methylphenidate Market >$15 billion ADHD market y y i approximately 19.7 million TRx’s and $4.2 billion in sales in 2015 Many ph products exclusivity in 2023 and growing; loses patent o Concerta, Adderall, Fi [~—«T PAD
Slide 23: KP415 Oral PK Profile in Rats
KP415 Oral PK Profile in Rats Oral PK Curves 100 5 90 4 %T na = 804 —-KP415 288% £ 70 —s-Dexmethylphenidate HC] 100% s 5 e 5 8 2 5 o ed i. = Note: MPH refers to dexmethylphenidate Studies conducted in rats | Ss
Slide 24: KP415 Reduced Abuse Potential
KP415 Reduced Abuse Potential Intranasal PK Curves Intravenous PK Curves 2.500 250 epic! —e-KPaIS . Se wPiHicl —e-KPat8 Z 20m 3 : 8 g F # 1500 E 5 3 8 3 5 é 8 4,000 ® B 500 3 = 3 &s = 2 AUC Coa AUC hCre or cr eo Note: methylphenidate hydrochloride. MPH-HCI refers to Studies conducted in rats.
Slide 25: KP415 Clinical Update
KP415 Clinical Update announced on July 14, 2016 p hase 1 p pt trial by y Tas
Slide 26: KemPharm Expected Near-Term News Flow
KemPharm Expected Near-Term News Flow Event Date KP511 (API) Intranasal HAL Study Data 2H 2016 KP415 IND Filing 2H 2016 KP415 Human POC 2H 2016 KP201/IR IND Filing 2H 2016 1Aay oe
Slide 27: Q2 2016 Financial Update
Q2 2016 Financial Update . ival restricted cash. bl iti d i $ f June 30, 2016 6 $ 2016 2 2016 net income of 8 8M, or $0.59 per basic share, and ($0.58) net loss per diluted share or ($2.45) per basic and diluted share o Net income for i y i ir value of th te dearivyaati iability . it $9.3M vs. $6.0M
Slide 28: Pharm
K Pharm jdrumm@tiberend.com
Kempharm — Canaccord Genuity 36th Annual Growth Conference (August 2016) on 6ix