Zevra Therapeutics, Inc. · NASDAQ:ZVRA
Zevra Therapeutics — Q2 2023 Earnings Presentation
13 slides from Zevra Therapeutics's earnings presentation, Aug 14, 2023
Slide 1: Second Quarter 2023 Financial Results
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Slide 2: Cautionary Note Regarding Forward-Looking Statements
UALAL AA Ne _\\ Cautionary Note Regarding SZEV Forward-Looking Statements 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
Slide 3: Second Quarter 2023 Overview
SZEVRA THERAPEUTICS Second Quarter 2023 Overview * Christal Mickle, Chief Development Officer, Co-Founder, interim CEO and President Highlights and Program Updates + Christal Mickle Second Quarter 2023 Financial Results and 2023 Financial Guidance + R.LaDuane Clifton, Chief Financial Officer Q&A Ses
Slide 4: Q2 2023 Overview
SZEVRA Q2 2023 Overview THERAPEUTICS * Multiple near-term clinical and regulatory catalysts for value creation * Building key functions and capabilities to support successful arimoclomol launch, if approved * In-house commercial team provides foundation to bring therapies to patients EAPs and patien
Slide 5: Pre-Submission Meeting with FDA was Productive and Collaborative
Pre-Submission Meeting with FDA was Productive and Collaborative Complete Response Letter (CRL) and FDA feedback gathered through multiple interactions/meetings has provided added clarity on resubmission package. COMPLETE RESPONSE LETTER Sufficiency of validation and reliability of the Niemann-Pick
Slide 6: Strategic Imperatives to Ensure Successful Launch of Arimoclomol
4.1. _Saa\\ Strategic Imperatives to Ensure Successful “ZEVRA Launch of Arimoclomol Patient advocacy relationships support adoption with a small and focused commercial team Ono Develop NPC market through Establish arimoclomol as foundational disease awareness and patient identification treatment for
Slide 7: Phase 2 Clinical Trial of KP1077 in IH
Phase 2 Clinical Trial of KP1077 in IH PHASE 2 TRIAL (N=48) Part 1: » Five-week open-label titration phase * Patients optimized to one of the four doses of SDX (80, 160, 240, or 320 mg/day) Part 2: » Two-week randomized, double- blind, withdrawal phase * 2/3 receive active; 1/3 placebo * 50% receive
Slide 8: KP1077 Opportunity in Rare Sleep Disorders
QV KP1077 Opportunity in Rare Sleep Disorders SZ Sue Lead clinical program in idiopathic hypersomnia (IH) with potential to expand into narcolepsy
Slide 9: Update on Partnered Asset: AZSTARYS
QZ Update on Partnered Asset: AZSTARYS® THERAPEUTICS Commercial Product Delivering Growing Value — . INDICATED FOR Surpassed $25 million in annual net Cy] TREATMENT OF ADHD . . ‘CD IN PATIENTS 6 YEARS OF AGE AND OLDER sales; Zevra earned $5 million net sales milestone \/]| APPROVED BY U.S. FDA IN MA
Slide 10: Financial Position is a Source of Strength
Financial Position is a Source of Strength THERAPEUTICS Q2 2023 Financial Results + Net Revenue: * Q2 2023 was $8.5M; derived primarily from AZSTARYS® milestone payment of $5M, French EAP reimbursements of $2.8M andAZSTARYS royalties of $0.8M + Net Loss: * Q2 2023 was ($5.1M), or ($0.15) per basic a
Slide 11: 2023 Financial Guidance
2023 Financial Guidance THERAPEUTICS Cash balance remains strong, with potential to realize milestone revenue Available cash, cash equivalents and investments expected to extend cash runway into 2026 * Current operating plan includes the expected reimbursements from the French arimoclomol EAP, the f
Slide 12: Q&A Session
Slide 13: Significant Value Creation through Continued Execution
VA SSSANY Pre-submission meeting with FDA was productive and collaborative; no change in strategy Full NDA package expected to be submitted in Q4 2023 Building key functions and capabilities to support successful arimoclomol launch, if approved EAPs and patient advocacy relationships to support prod