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Zevra Announces Final Results of 2025 Annual Meeting of Stockholders
Globenewswire· 2025-05-29 20:35
Core Points - Zevra Therapeutics, Inc. announced the re-election of Wendy L. Dixon, Ph.D. and Tamara A. Favorito to its Board of Directors, serving until the 2028 Annual Meeting [1][2] - The Board expressed gratitude for stockholder participation and support, viewing the election results as a validation of their strategic direction and progress over the past two years [2][4] - Daniel J. Mangless attempted to nominate alternative candidates but failed to meet SEC proxy rules and the Company's bylaws, resulting in his nominations being disregarded [2][3] Company Strategy and Performance - The Board and management reaffirmed their commitment to driving growth and executing their strategic plan, focusing on creating long-term value for stockholders [2][4] - The election results indicated strong stockholder support for the Board's industry expertise and commitment to delivering value [4] Financial Oversight - Stockholders approved the appointment of Ernst & Young LLP as the independent auditors for the fiscal year ending December 31, 2025 [5] Company Overview - Zevra Therapeutics is a commercial-stage company dedicated to developing therapies for rare diseases, utilizing data-driven strategies to overcome drug development challenges [6]
All Three Leading Proxy Advisory Firms – ISS, Glass Lewis, and Egan-Jones – Recommend Zevra Stockholders Vote FOR the Company's Director Nominees
GlobeNewswire News Room· 2025-05-21 11:30
ISS, Glass Lewis, and Egan-Jones Unanimously Conclude Mangless Has Not Made a Compelling Case for Change Board and Management Urge Stockholders to Follow Proxy Advisors' Recommendation and Vote "FOR" Wendy L. Dixon, Ph.D. and Tamara A. Favorito on the WHITE Proxy Card and "WITHHOLD" for Mangless Nominees CELEBRATION, Fla., May 21, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) ("Zevra," or the "Company"), a commercial-stage company focused on providing therapies to people living with rar ...
Zevra Therapeutics(ZVRA) - 2025 FY - Earnings Call Transcript
2025-05-20 17:30
Zevra Therapeutics (ZVRA) FY 2025 Conference May 20, 2025 12:30 PM ET Speaker0 Alright. Good afternoon, everyone. My name is Brandon Folks. I'm one of the biopharma analysts here at H. C. Wainwright. And joining me for a fireside chat from Zebra Therapeutics is CEO, Neil McFarlane. Neil, thank you very much. Speaker1 Yeah. Thank you for having us. Speaker0 So maybe just to start, do you wanna just spend a few minutes giving people a quick overview of Zebra and the products that you currently have? Speaker1 ...
Zevra Therapeutics (ZVRA) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-13 22:20
Zevra Therapeutics (ZVRA) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.21. This compares to loss of $0.40 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 71.43%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.39 per share when it actually produced a loss of $0.67, delivering a surprise of -71.79%.Over the last four quart ...
Zevra Therapeutics(ZVRA) - 2025 Q1 - Earnings Call Transcript
2025-05-13 21:32
Zevra Therapeutics (ZVRA) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Nichol Ochsner - Vice President of Investor Relations & Corporate CommunicationsNeil McFarlane - President & CEOJoshua Schafer - CCOR. LaDuane Clifton - CFO, Secretary & TreasurerSumant Kulkarni - Managing DirectorJason Butler - Managing Director & Biotechnology Equity ResearchEddie Hickman - Vice President Conference Call Participants Lachlan Hanbury-Brown - Biotech Equity Research Analyst Operator Good afternoon ...
Zevra Therapeutics(ZVRA) - 2025 Q1 - Earnings Call Transcript
2025-05-13 21:30
Financial Data and Key Metrics Changes - In Q1 2025, the company reported net revenue of $20.4 million, with $17.1 million from MyPlifa, $0.1 million from Olpruva, and $2.3 million in net reimbursements from the French EAP for Aramcholamol [29][30] - Operating expenses for Q1 were $22.8 million, a decrease of $0.6 million compared to the same quarter last year [30] - The net loss for Q1 2025 was $3.1 million, compared to a net loss of $16.6 million in the same quarter a year ago [30][31] - Total cash, cash equivalents, and investments as of March 31, 2025, were $68.7 million, a decrease of $6.8 million from December 31, 2024 [30][31] Business Line Data and Key Metrics Changes - MyPlifa's launch has exceeded expectations, with 122 prescription enrollment forms received since launch, indicating that approximately one-third of diagnosed NPC patients in the U.S. have been enrolled [20][21] - Olpruva received a total of 28 prescription enrollment forms since its initial availability, with five forms received in Q1 2025 [12][27] - The company has achieved 38% of covered lives for MyPlifa, which is in line with expectations at this stage of the launch [21][22] Market Data and Key Metrics Changes - The company is focusing on expanding MyPlifa's availability outside the U.S., with plans for a marketing authorization application in Europe in the second half of the year [11] - The European market for NPC is well established, with approximately 1,100 people estimated to be living with the disease [11] Company Strategy and Development Direction - The company is executing on four strategic pillars: commercial excellence, pipeline and innovation, talent and culture, and corporate foundation [5][8] - The focus is on bringing innovative therapies to patients with rare diseases, with a strong emphasis on MyPlifa as a cornerstone treatment for NPC [17][33] - The company is also assessing strategic alternatives for its Phase III ready asset KP1077 for rare sleep disorders [6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early success of MyPlifa and the refined marketing strategy for Olpruva, indicating a strong position for future growth [33] - The company believes it is well positioned to support its strategic priorities and execute on its long-term vision, independent from capital markets [31][32] Other Important Information - The company has successfully monetized its Pediatric Rare Disease Priority Review Voucher, adding $148.3 million of non-dilutive capital to its balance sheet [8][31] - The company is committed to patient access and comprehensive patient services through its in-house program, Amplify Assist [27] Q&A Session Summary Question: Details on the number of patients on MyPlifa and reimbursement status - The company received 122 enrollments since launch, with the majority of patients actively on the drug, while some are in the benefits investigation process [36] Question: Reasons for reimbursement denials for MyPlifa - Initial denials are common for rare disease products, primarily due to prior authorization requirements, but the company has been successful in securing coverage through medical exception processes [39][40] Question: Visibility on patient cohorts and enrollment cadence - The company estimates around 600 undiagnosed patients and 300 diagnosed patients, with ongoing efforts to raise awareness and facilitate treatment [47][59] Question: Inventory levels at the end of the quarter - The company is managing inventory closely and maintaining target levels as it supports patient needs during the early launch phase [50] Question: Qualitative metrics on refill rates and patient retention - The majority of patients receiving active drug have continued to refill, reflecting the clinical benefit and durability of MyPlifa [54] Question: Coverage details and impact on patient access - 38% of covered lives have access to MyPlifa, with ongoing efforts to increase this percentage as more plans evaluate the product [63][64]
Zevra Therapeutics(ZVRA) - 2025 Q1 - Quarterly Report
2025-05-13 21:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From to Commission File Number: 001-36913 Zevra Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 20-5894398 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. ...
Zevra Reports First Quarter 2025 Financial Results and Corporate Update
Globenewswire· 2025-05-13 20:05
Q1 2025 net revenue of $20.4 million, driven by product net revenue of $17.2 million Completed sale of PRV for gross proceeds of $150 million, positioning balance sheet to drive the Company’s commercial launches and development programs Company to host conference call and webcast today, May 13, 2025, at 4:30 p.m. ET CELEBRATION, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living ...
Zevra Therapeutics (ZVRA) 2025 Conference Transcript
2025-05-07 16:30
Zevra Therapeutics (ZVRA) 2025 Conference May 07, 2025 11:30 AM ET Speaker0 We're gonna go ahead and get started. Thanks again everybody for joining us this morning at the Citizens Life Sciences Conference. Really pleased to be joined next by Zevra Therapeutics, CEO Neil McFarlane, CFO LeDuane Clifton. Zevra is a company focused on, developing and commercializing therapies in in the rare disease space. The company has a portfolio now of approved products. The the the one we're focused on most near term is i ...
Zevra Therapeutics Announces Details for Q1 2025 Financial Results Call
Globenewswire· 2025-05-06 11:30
Company will host conference call at 4:30 p.m. ET on Tuesday, May 13, 2025CELEBRATION, Fla., May 06, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced it will report corporate and financial results for the first quarter 2025 on Tuesday, May 13, 2025. The Company will issue a news release after the market closes and host a conference call/audio webcast at 4: ...