Zevra Therapeutics, Inc. · NASDAQ:ZVRA

Zevra Therapeutics — Kempharm — Corporate Update (February 2018)

11 slides from Zevra Therapeutics's corporate update, Feb 23, 2018

  1. Slide 1: Apadaz FDA Approval

    K Pharm Apadaz™ FDA Approval

  2. Slide 2: Cautionary Note Regarding Presentation Information

    Cautionary Note Regarding Presentation Information This presentation may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking s

  3. Slide 3: Apadaz Update — Conference Call Participants

    Apadaz™ Update — Conference Call Participants + Travis Mickle, Ph.D. - President & Chief Executive Officer + Rusty Johnson, M.B.A. — Chief Business Officer + Dan Cohen, M.A.L.S.— EVP, Government & Public Relations

  4. Slide 4: Apadaz Approval

    Apadaz™ Approval Y Announced FDA Approval of Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain + First prodrug of hydrocodone/acetaminophen to be approved by FDA + Immediate release (IR) combination of KemPharm's prodrug of hydrocodone, benzhydrocodone, and aceta

  5. Slide 5: Apadaz Product Overview

    Apadaz™ Product Overview + IR opioid fixed-dose combination product comprised of 6.67 mg benzhydrocodone HCI (a prodrug of hydrocodone equivalent to 7.5 mg hydrocodone bitartrate) and 325 mg APAP Prodrug consists of hydrocodone plus benzoic acid Developed using a 505(b)(2) regulatory pathway o Bioeq

  6. Slide 6: Label — Key Areas of Differentiation

    Apadaz Label — Key Areas of Differentiation Section 2 (Dosage and Administrat n) APADy + 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

  7. Slide 7: Label — Key Areas of Differentiation

    Apadaz Label — Key Areas of Differen ition Intranasal Clinical Abuse Potential In Vitro Testing + Overthe first 2 hours post-dosing (AUCO-0.5, + The efficiency of extracting benzhydrocodone ‘AUCO-1, and AUCO-2), the cumulative from APADAZ was similar comparedto the hydrocodone exposure was lower fol

  8. Slide 8: Label — Key Areas of Differentiation

    Apadaz Label -- Key Areas of Differentiation 100 Count Bottle Blister Pac Rx Only NOC 70040-0167-3 APADAZ™ € (benzhydrocodone and acetaminophen) 612mg / 325 mg tele (aie Bee rn sa3s6T090

  9. Slide 9: Commercialization Strategy

    Apadaz Commercialization Strategy KemPharm is pursuing two potential strategies for commercializing Apadaz, neither strategy requires KemPharm to establish its own sales force. Non-traditional PBM Partnerships Pharma Partnership + Collaborative partnerships with + Partnership with a US-based or lead

  10. Slide 10: KemPharm Expected Milestones

    KemPharm Expected Milestones Product Event Date KP484 IND Filing rT an KP415 Initiate Pivotal Efficacy Study 2017—CY 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 —Or

  11. Slide 11: Apadaz FDA Approval

    K Pharm Apadaz™ FDA Approval

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