Zevra Therapeutics, Inc. · NASDAQ:ZVRA
Zevra Therapeutics — Kempharm — Investor Presentation (January 2022)
21 slides from Zevra Therapeutics's investor presentation, Jan 19, 2022
Slide 1: KemPharm Management Presentation
| 7 KemPharm Management Presentation January 2022
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 1996. Forward-looking statements include all statements thet 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: 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 Y Build a highly differentiated pipeline of development assets with multiple clinical and regulatory milestones Y Focus on high-value areas with significant unmet needs
Slide 5: Pipeline of Product Candidates with Substantial Milestones in 2022 and Beyond
Pipeline of Product Candidates with Substantial Milestones in 2022 and Beyond Anticipated Timing of Indication Product Candidate Phase of Development Set Migetone Rare Sleep Disorders Idiopathic Hypersomnia (IH) KP1077 Phase 2 03 2022 Narcolepsy Typetandit | KP1077 Phase 2 4 2022 Indicensing, acquis
Slide 6: Upcoming Clinical, Reg and BD Milestones Create Potential Near-Term Value
Upcoming Clinical, Reg and BD Milestones Create Potential Near-Term Value Milestone 12022 22022 3 2022 942022 Q12023, @22023, KP1077 for 1H Type B meeting with FDA IND filing | Phase 1 CV differentiation rial Phase 2 trial ] | KP1077 for Narcolepsy | Type B meeting with FDA. ] ] IND filing T y | Pha
Slide 7: SDX Product Candidate: KP1077
SDX Product Candidate: KP1077 For the Treatment of Idiopathic Hypersomnia (IH)
Slide 8: 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? © Total population may be much larger (not seeking treatment, undiagnosed, misdiagnosed) Symptoms are highly debilitating — IH can be more debilitating tha
Slide 9: If Differentiated, 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® BrandName DEA Sponsor Features Annual Cost Active Ingredient ‘Schedule + Approved for; cenraly acting depressant Xywav (mixed oxybate i uty" Dosedtwice at night; once before bed and another 4 hs. ate
Slide 10: KP1077 Product Candidate Overview
KP1077 Product Candidate Overview + 100% Serdexmethylphenidate (SDX) product with multiple dosing options depending on patient needs © Dosed either 1x (at bedtime) or 2x (at bedtime and upon waking) Features and benefits already demonstrated: SDX has already been designated C-IV by DEA © No DDI pote
Slide 11: Predicted Pharmacokinetics for Two Potential Dosing Regimens of SDX
Predicted Pharmacokinetics for Two Potential Dosing Regimens of SDX (Once Daily or B.1.D) PK after Multiple Oral Doses of SDX ‘Analyte = d-MPH once Daly (20 pm) BID (10 pm and 8 am) MPH Concentration (re/mt) of 10PM 2AM 2AM 4AM GAM GAM 10AM12PM 2PM 4PM GPM BPM 10PM Plasma concentrations were estimat
Slide 12: KP1077 Value Proposition: Addressing Key Unmet Needs
KP1077 Value Proposition: Addressing Key Unmet Needs + Idiopathic hypersomnia is sometimes considered more debilitating than narcolepsy © Sleep inertia/waking: nightly dosing provides increased d-methylphenidate (d-MPH) concentrations upon waking © “Brain fog’: morning dosing provides long-lasting d
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 © Brain fog is so debilitating that current, tolerable stimulant treatment dose
Slide 14: 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 Itis estimated that ~37K patients are currently diagnosed with |H and actively seeking treatment’ based on Potential Xywav? received FDA approval in August 20
Slide 15: Business Development Focus
Business Development Focus Pipeline Additions through In-Licensing, Other Product Opportunities
Slide 16: 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: © Commercial Opportunity (physician/KOL input, payor research, competitive landscape) © Risk (clinical, development, regulatory) © Time, C
Slide 17: Additional Serdexmethylphenidate (SDX) Opportunities
Additional Serdexmethylphenidate (SDX) Opportunities + 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-II © SDX has a unique PK profile allowing for gradual and continuous release throughout the day ©
Slide 18: Outlook and Milestones
Outlook and Milestones Strong Foundation Built with AZSTARYS® and a Solid Balance Sheet
Slide 19: AZSTARYS Launch Gaining Traction with National Rollout and Strong Balance Sheet
AZSTARYS® Launch Gaining Traction with National Rollout and Strong Balance Sheet Supports Ongoing Development Recent wins in payor access has led Corium to accelerate their national rollout of AZSTARYS. o As of Jan 1, 2021, over 100 million commercial and Medicaid lives have access to AZSTARYS, whic
Slide 20: Clinical and Regulatory Milestones in 2022
Clinical and Regulatory Milestones in 2022 Milestone 12022 022022 932022 942022 KP1077 for 1H Type B meeting with FDA IND filing Phase 1 CV differentiation trial Phase 2 trial initiation KP1077 for Narcolepsy Type B meeting with FDA IND filing Phase 2/8 trial initiation kP879 Final trial results eq
Slide 21: KemPharm: Looking Ahead
KemPharm: Looking Ahead ¥ Continuing efforts to build a highly differentiated pipeline of developmentassets v Focusedon high-value areas with significant Initiation of ff Opportunities unmet needsin CNS/rare disease with KP1077 to Further potential to internally commercialize Development Expand Prog