Zevra Therapeutics, Inc. · NASDAQ:ZVRA
Zevra Therapeutics — Kempharm — Investor Presentation (February 2022)
26 slides from Zevra Therapeutics's investor presentation, Feb 22, 2022
Slide 1: KemPharm Management Presentation
| a KemPharm Management Presentation February 2022 “a Trademarks herein are held by their respective owners.
Slide 2: Cautionary Note Regarding Presentation Information
Cautionary Note Regarding Presentation Information This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, includin
Slide 3: Innovative pharmaceutical company for CNS and rare diseases
Innovative pharmaceutical company discovering and developing novel treatments for CNS and rare diseases
Slide 4: Experienced Management Team in Corporate and Drug Development
Experienced Management Team in Corporate and Drug Development Travis C. Mickle, PhD President and CEO R. LaDuane Clifton, CPA CFO Sven Guenther, PhD EVP R&D ae A = < ae A ee apadaz’ K Aetna: } Meee apadaz’ and dexmethyphensote ees eieeetneriste inuyloaige nd Vyvalitc (lisdexamfetamine dimesylate) Pa
Slide 5: KemPharm Leverages its LAT Prodrug Technology to Improve Approved Drugs
KemPharm Leverages its LAT® Prodrug Technology to Improve the Attributes of Approved Drugs eo” ap are —_ —_ Approved Drug with Ligand Prodrugwith Cleaved Drug through Sub-Optimal Improved Attributes Human Metabolic Properties Process Select FDA-approved and widely prescribed drug for improvement, se
Slide 6: Focused on Creating Future Value in High Value Areas with Significant Unmet Needs
Focused on Creating Future Value in High Value Areas with Significant Unmet Needs; Solid Financial Foundation Creates Opportunities Strategic Focus on CNS/Rare Disease KP1077 for the Treatment of Idiopathic Hypersomnia (IH) Other SDX Product Opportunities AZSTARYS® License Strong Balance Sheet Build
Slide 7: Pipeline of Product Candidates with Substantial Milestones in 2022 and Beyond
Pipeline of Product Candidates with Substantial Milestones in 2022 and Beyond 1g of Next Milestone Product Candidate Phase of Development Rare Sleep Disorders Idiopathic Hypersomnia (IH) KP1077 Phase 2 Q3 2022 Narcolepsy Type | and Il KP1077 Phase 2 Q4 2022 Sleep Disorders TBD Iinvogrem: oo el ‘ H2
Slide 8: SDX Product Candidate: KP1077
SDX Product Candidate: KP1077 For the Treatment of Idiopathic Hypersomnia (IH)
Slide 9: Idiopathic Hypersomnia (IH)
Idiopathic Hypersomnia (IH) * There are 10.3 IH patients per 100,000 people in the US" © ~37,000 diagnosed IH patients actively seeking treatment? o Total population may be much larger (not seeking treatment, undiagnosed, misdiagnosed) + Symptoms are highly debilitating — IH can be more debilitating
Slide 10: KP1077 Product Candidate Overview
KP1077 Product Candidate Overview + 100% Serdexmethylphenidate (SDX) productwith multiple dosing options depending on patient needs o Dosed either QD (once at bedtime) or BID (twice daily at bedtime and upon waking) Features and benefits already demonstrated: o SDX has already been designated C-IV b
Slide 11: KP1077 Could Gain Significant Share if Priced Between Provigil and Xywav/Wakix
If Differentiated, KP1077 Could Gain Significant Share if Priced Between Provigil® and Xywav®/Wakix® Brand Name DEA Active Ingredient Schedule * Approved for IH; centrally acting depressant Xywav (mixed oxybate Jazz Cll + Dosed twice at night; once before bed and another 4 hrs later Highest dose: sa
Slide 12: KP1077 Value Proposition: Addressing Key Unmet Needs
KP1077 Value Proposition: Addressing Key Unmet Needs + Idiopathic hypersomnia can be more debilitating than narcolepsy o Sleep inertia/waking: nightly dosing provides increased d-methylphenidate (d-MPH) concentrations upon waking o “Brain fog”: morning dosing provides long-lasting d-MPH concentratio
Slide 13: KP1077 Value Proposition: Addressing Key Unmet Needs
KP1077 Value Proposition: Addressing Key Unmet Needs + Many comorbidities and patient demographics complicate treatment; current off-label treatment options have significant limitations and provide limited symptom relief o Brain fog is so debilitating that current, tolerable stimulant treatment dose
Slide 14: Predicted Pharmacokinetics for Two Potential Dosing Regimens of SDX
Predicted Pharmacokinetics for Two Potential Dosing Regimens of SDX (Once Daily or B.I.D) PK after Multiple Oral Doses of SDX Analyte = d-MPH 2 8 nN & N 8 — Once Daily (10 pm) —BID (10 pmand 8 am) 3S d-MPH Concertration (ng/mL) a a 0 10PM12AM 2AM 4AM 6AM 8AM 10AM12PM 2PM 4PM 6PM 8PM 10PM Plasma conc
Slide 15: KP1077 Could Capture a Large Share of the IH Market
KP1077 Could Capture a Large Share of the IH Market Based on Potential Clinical Differentiation and Combination Use Illustrative Market Share based on Potential Differentiation Itis estimated that ~37K patients are currently diagnosed with IH and actively seeking treatment’ Xywav® received FDA appro
Slide 16: Business Development Focus
Business Development Focus Maximizing Serdexmethylphenidate Value Potential Pipeline Additions Through In-Licensing
Slide 17: Serdexmethylphenidate (SDX) Platform Potential
Serdexmethylphenidate (SDX) Platform Potential * SDX also provides an opportunity to explore indications outside ADHD and IH o SDX is the only C-IV methylphenidate-based product; all others are C-Il o SDX has a unique PK profile allowing for gradual and continuous release throughout the day o Curren
Slide 18: Pipeline Expansion Strategy to Accelerate Value Creation
Pipeline Expansion Strategy to Accelerate Value Creation + Our strategic focus, including review of internal development candidates, is guided by these criteria: o Commercial Opportunity (physician/KOL input, payor research, competitive landscape) o Risk (clinical, development, regulatory) o Time, C
Slide 19: AZSTARYS
AZSTARYS® D-Methylphenidate Prodrug Product for the Treatment of ADHD
Slide 20: AZSTARYS Product Highlights
AZSTARYS® Product Highlights * 70% prodrug of d-MPH (serdexmethylphenidate, or SDX) co-formulated with 30% immediate release d- MPH + AZSTARYS® features and benefits o Indicated for the treatment of ADHD in patients 6 years of age and older o Can be administered with or without food o Capsule can be
Slide 21: AZSTARYS - U.S. Commercial Launch
ASTARYS® - U.S. Commercial Launch July 2021, Corium, an affiliate of GPC, launched AZSTARYS (serdexmethylphenidate and dexmethylphenidate capsules) in the U.S. o As of Jan 1, 2021, over 100 million commercial and Medicaid lives have access to AZSTARYS, which is 2x coverage from Oct 1, 20211 o Recent
Slide 22: License Agreement with Commave (Affiliate of GPC)
License Agreement with Commave (Affiliate of GPC) License agreement with Commave, an affiliate of GPC, was entered into Sept 2019 for AZSTARYS® and KP484 Commercial rights assigned to Corium, another affiliate of GPC, led by ex-Shire team o Perry Sternberg (CEO) and key commercial team members led V
Slide 23: Financial Update
Financial Update
Slide 24: Q3 2021 Results; Balance Sheet Demonstrates Solid Financial Position
Q3 2021 Results; Balance Sheet Demonstrates Solid Financial Position + Revenue of $2.0M, derived primarily from consulting service fees + Net loss ($1.8M), or ($0.05) per basic and diluted share + Net operating loss was ($2.2M), which increased by $1.0M compared to Q3 2020 due to an increase in oper
Slide 25: Upcoming Clinical, Reg and BD Milestones Create Potential Near-Term Value
Upcoming Clinical, Reg and BD Milestones Create Potential Near-Term Value Milestone Q12022 Q2 2022 Q3 2022 Q4 2022 Q12023 Q2 2023 KP1077 for 1H Type B meeting with FDA IND filing Phase 1 CV differentiation trial Phase 2 trial KP1077 for Narcolepsy Type B meeting with FDA | IND filing | Phase 2/3 tri
Slide 26: KemPharm: Looking Ahead
KemPharm: Looking Ahead ¥ Continuing efforts to build a highly differentiated pipeline of developmentassets v Focusedon high-value areas with significant Opportuni unmet needs in CNS/rare disease with to Further potential to internally commercialize Expand v KP1077: Substantial high-value opportunit