-+ 0.00%
-+ 0.00%
-+ 0.00%

Zevra Details Strong Growth, Director Re-Election and Strategic Vision for Rare Disease Treatments in Stockholder Letter Ahead of 2025 Annual Meeting

Benzinga·04/21/2025 11:26:32
Listen to the news

Zevra Therapeutics, Inc. (NASDAQ:ZVRA) ("Zevra", or "the Company"), a commercial-stage company focused on providing therapies for people living with rare disease, today announced it has filed its definitive proxy statement with the U.S. Securities and Exchange Commission (the "SEC") in connection with the Company's 2025 Annual Meeting of Stockholders ("Annual Meeting"), which is scheduled to take place on May 29, 2025. Stockholders of record as of April 4, 2025 will be entitled to vote at the Annual Meeting.

Zevra's Board of Directors strongly recommends that stockholders vote "FOR" the Company's two highly-qualified directors up for re-election on the WHITE proxy card – Wendy L. Dixon, Ph.D and Tamara A. Favorito, both of whom bring extensive public company board experience and life sciences management expertise to the Zevra Board. Both of these independent directors have contributed valuable perspectives that have helped accelerate the Company's progress and execution of its strategic goals.

In conjunction with the definitive proxy filing, Zevra is mailing a letter to stockholders detailing the decisive action the Company has taken over the past two years to transform Zevra into a stronger, growth-oriented commercial organization, which is poised to continue to drive significant stockholder value. The letter also addresses the attempt by an individual stockholder, Daniel J. Mangless, to replace two highly qualified directors with his nominees who could disrupt the clear progress underway and jeopardize Zevra's ability to deliver long-term value for stockholders.

As stockholders consider this important election, it is critical to remember that:

  • The proactive and refreshed Zevra Board and management team have a proven track record of success, as demonstrated by the continued progress and significant stockholder value creation during the last two years. Seven of eight directors have joined the Board since 2023 and Zevra's refreshed management team has launched two rare disease therapies, rapidly expanded the Company's commercial capabilities, and positioned its pipeline for continued success.



     
  • The ongoing execution of Zevra's strategy is designed to continue driving value over the coming months and years.



     
  • Zevra's Board nominees are proven, experienced public company leaders and directors who have the requisite company and industry expertise and fulfill the essential requirements for effective governance of a rapidly growing commercial-stage rare disease company. During their tenure, the Board's nominees have initiated and overseen substantial improvements to the Company.



     
  • Despite owning just 2.8% of the Company and having already had three nominees elected to the Board in 2023, Mr. Mangless is now actively seeking two additional Board seats without providing any clear strategy or explanation of what he intends to accomplish or how he proposes to increase stockholder value. If Mr. Mangless' two nominees are elected this year, his nominees would have five Board seats in total, representing a majority of the Board. This latest attempt raises questions about the amount of undue influence one stockholder should have on the Board. In his own proxy filing, Mr. Mangless acknowledges that if his two nominees are elected, the five nominees that he will have added to the Board "will potentially be able to implement any actions that they may believe are necessary..."



     
  • Mr. Mangless has not disclosed any specific strategies, plans, or new ideas to improve Zevra's business – in fact, he has expressed agreement with the recent actions that Zevra has taken, including the onboarding of Zevra's current leadership, yet he still appears focused on replacing two highly-qualified directors with his nominees who lack the necessary expertise, independence, and proper business judgment and acumen to serve Zevra's stockholders effectively. Mr. Mangless' nominees are a proxy solicitor with no relevant Board or industry experience, and a former CEO, both of whom have previously destroyed significant stockholder value. The Zevra Board believes that adding his nominees will put stockholders‘ investments in Zevra at risk.



     
  • Mr. Mangless' nominees, Arthur Regan and Dr. Travis Mickle, have track records of destroying stockholder value in public company leadership roles. During Regan's tenure as a director at US Wats, US Wats' stock price fell 63.9%. While Dr. Mickle was CEO of Zevra, its stock price plummeted 97.4%.1

     

Zevra's letter to stockholders and other materials regarding the Board's recommendation for the 2025 Annual Meeting can be found on the Company's investor relations website at https://investors.zevra.com/.

The full text of the letter follows:

Dear Fellow Stockholders,

The Zevra Board of Directors and management team have taken decisive action over the past two years, transforming the Company and driving significant stockholder value creation.

This transformation began in October 2023, when your Board appointed Neil McFarlane as President and CEO of Zevra, following a thorough process to find the right leader to accelerate Zevra's progress and harness our pipeline of innovative rare disease therapies. Since then, we have launched two rare disease therapies and have been rapidly expanding Zevra's commercial capabilities. We completed a comprehensive review of our development pipeline to facilitate investment in the most promising, highest return opportunities. At the same time, we have added significant expertise to support the Company's growth and help us continue to drive operational excellence across our commercial and pre-commercial programs. Further, we have strengthened Zevra's balance sheet, providing the Company with ample financial flexibility to continue investing in growth, without needing incremental funding from the capital markets.

In late 2024, your Board and management team detailed a clear and comprehensive five-year strategic plan to drive long-term growth and patient impact. We are making significant progress as we successfully drive towards our clear priorities and achieve our vision of positioning Zevra as a leading global rare disease company.

The results of our execution speak for themselves: Our strategy has enabled Zevra to deliver superior returns for our stockholders. During the last 1-year and 2-year periods, your Board and management team have delivered total stockholder returns of 54.1% and 14.8%, respectively, all in excess of the comparable biotech sector and the Russell 2000. As seen below, since Mr. McFarlane was appointed CEO in October 2023, Zevra has achieved impressive total stockholder returns of 54.8%.2



 

Against this backdrop of significant commercial progress and superior returns, you have an important decision to make at our upcoming Annual Meeting on May 29, 2025. Your Board has two independent directors up for re-election, Wendy L. Dixon, Ph.D., who has served as a director since April 2023, and Tamara A. Favorito, who has served as a director and Chair of the Audit Committee since August 2021 and as our Board Chair since May 2023. Dr. Dixon and Ms. Favorito bring extensive public company board experience, deep knowledge of Zevra, and life sciences management expertise to the Zevra Board. Both directors have contributed valuable perspectives that have helped accelerate the Company's progress and execution of its strategic goals.

Meanwhile, Daniel J. Mangless, an individual stockholder, has nominated Travis C. Mickle, Ph.D., Zevra's former President and CEO, and Arthur C. Regan, a proxy solicitor, for election to your Board. We believe that adding a former CEO, who presided over a period of significant stockholder value destruction during his tenure at Zevra and cannot be considered independent under SEC and stock exchange rules, as well as a proxy solicitor with no industry experience risks significant disruption to Zevra's ongoing progress and ability to continue delivering sector-leading returns to stockholders. Further, their appointments would distract from the Company's continued disciplined execution of its five-year strategic plan and value-creation initiatives.

Zevra's Board recommends that stockholders reject these efforts by Mr. Mangless. Please discard any blue proxy card sent to you by Mr. Mangless.

To elect the Zevra Board's nominees, we encourage you to vote today – no matter how many or how few shares you own –online or by signing and dating the enclosed WHITE proxy card and returning it in the postage-paid envelope provided.

As you consider this important election, it is critical to remember that:

  • Your proactive and refreshed Zevra Board and management team have a proven track record of success, as demonstrated by the continued progress and significant stockholder value creation during the last two years. Seven of eight directors have joined the Board since 2023, and Zevra's refreshed management team executed the launch of two rare disease therapies, rapidly expanded the Company's commercial capabilities and positioned its pipeline for continued success.



     
  • The ongoing execution of Zevra's strategy is designed to continue driving value over the coming months and years.



     
  • Zevra's Board nominees are proven, experienced public company leaders and directors who have the requisite company and industry expertise and fulfill the essential requirements for effective governance of a rapidly growing commercial-stage rare disease company. During their tenure, the Board's nominees have initiated and overseen substantial improvements to the Company.



     
  • Despite owning just 2.8% of the Company and having already had three nominees elected to the Board in 2023, Mr. Mangless is now actively seeking two additional Board seats without providing any clear strategy or explanation of what he intends to accomplish or how he proposes to increase stockholder value. If Mr. Mangless' two nominees are elected this year, his nominees would have five Board seats in total, representing a majority of the Board. This latest attempt raises questions about the amount of undue influence one stockholder should have on the Board. In his own proxy filing, Mr. Mangless acknowledges that if his two nominees are elected, the five nominees that he will have added to the Board "will potentially be able to implement any actions that they may believe are necessary..."



     
  • Mr. Mangless has not disclosed any strategies, plans, or new ideas to improve Zevra's business – in fact, he has expressed agreement with the recent actions that Zevra has taken, including the onboarding of Zevra's current leadership, yet he still appears focused on replacing two highly-qualified directors with his nominees who lack the necessary expertise, independence, and proper business judgment and acumen to serve Zevra's stockholders effectively. Mr. Mangless' nominees are a proxy solicitor with no relevant Board or industry experience, and a former CEO, both of whom have previously destroyed significant stockholder value. The Zevra Board believes that adding his nominees will put stockholders‘ investments in Zevra at risk.



     
  • Mr. Mangless' nominees, Arthur Regan and Dr. Travis Mickle, have track records of destroying stockholder value in public company leadership roles. During Regan's tenure as a director at US Wats, US Wats' stock price fell 63.9%. While Dr. Mickle was CEO of Zevra, its stock price plummeted 97.4%.3

     

We ask you a simple question: Would you rather have a proven team with a clear strategy, strong momentum, relevant expertise, and a track record of increasing stockholder value, or risk distraction, disruption, and potential destruction of the Company's value by a single stockholder with unqualified director nominees and no stated business strategy? We urge you to stand with management and reject the blue proxy card with Mr. Mangless' nominees.

Your Board and Management Team are Actively Delivering Significant Progress as we Continue Zevra's Transformation into a Leading Rare Disease Company

Over the past two years, your Board and management team have been actively transforming Zevra into a more efficient, more focused organization that is better positioned to create value for our patients and stockholders. In the third quarter of 2024, we introduced our five-year strategic plan, built on four key pillars that have informed our priorities and investments as we continue to accelerate Zevra's commercial momentum: (1) Commercial Excellence, (2) Pipeline and Innovation, (3) Talent and Culture, and (4) Corporate Foundation.

1.  Delivering Commercial Excellence – In 2024, we successfully commercialized and launched Zevra's first two products. Since then, we have maintained our active focus on driving best-in-class commercial excellence.

  • In September 2024, we received approval from the U.S. Food and Drug Administration for MIPLYFFA®, the first approved product in the U.S. for the treatment of Niemann-Pick disease type C (NPC). Alongside this approval, we received a Rare Pediatric Disease Priority Review Voucher (PRV), which Zevra recently sold for $150 million to further enhance our financial flexibility. MIPLYFFA became available to patients within eight weeks following approval, and with the support of the NPC community and strong execution by our team, we were able to quickly ensure a smooth transition for all U.S. Expanded Access Program (EAP) participants to MIPLYFFA as a commercial product.
  • Eight months earlier, in January 2024, we launched OLPRUVA®, Zevra's first-ever commercial product, for people suffering from certain urea cycle disorders (UCDs), and we have continued its growth while accelerating the establishment of our commercial footprint.

     

2.  Enhancing the Value of Zevra's Pipeline and Innovation – Throughout 2024, your Board and management team conducted a comprehensive, data-driven review to optimize and curate Zevra's portfolio. This review allowed us to focus our resources on development projects where Zevra is uniquely positioned to create the most value for patients and our stockholders – ensuring that we are investing in Zevra's most promising, highest return opportunities.

 

  • Launched Phase 3 DiSCOVER trial: Based on the results of our review, in mid-2024, we reinitiated recruitment for the Phase 3 DiSCOVER trial of celiprolol for the treatment of Vascular Ehlers-Danlos Syndrome (VEDS) as a potential treatment for a patient population with high unmet need.
  • Maximizing the Value of KP1077: In June, we announced positive topline results from our KP1077 Phase 2 trial in idiopathic hypersomnia at the 2024 Annual SLEEP Meeting. At the end of the third quarter, we completed our end-of-Phase 2 meeting. The FDA and Zevra reached alignment on a Phase 3 trial design and indicated that a single pivotal study with appropriate confirmatory evidence would be sufficient to submit a New Drug Application (NDA). As part of our pipeline review, we have determined that the best path forward to maximize the value of KP1077 is to explore strategic alternatives for advancing its clinical development and future commercialization.

     

3.   Optimizing Leadership Team with the Right Talent: As we have continued our momentum, we have also evolved our leadership team to ensure we have the right talent to support our continued growth into a leading rare disease commercial company.

 

  • In June 2024, we enhanced our executive leadership team with the appointments of Rahsaan Thompson as Chief Legal Officer, Secretary and Compliance Officer, and Alison Peters as Chief People Officer; we also consolidated our development and scientific functions under Adrian Quartel, our Chief Medical Officer.

4.   Strengthening Zevra's Corporate Foundation: We have continued our approach of disciplined capital allocation, focusing our investments on the highest return activities and actively enhancing our financial flexibility.

  • In April 2024, we bolstered Zevra's balance sheet by restructuring the Company's debt, using a new credit facility provided by premier biotech investors.
  • In September 2024, we secured a Rare Pediatric Disease Priority Review Voucher (PRV) with the approval of MIPLYFFA, which we sold this April for approximately $150 million, providing additional non-dilutive capital to fuel our commercial launches of MIPLYFFA and OLPRUVA, and further the development of celiprolol. We believe this transaction provides us with important financial flexibility to deliver on our strategic plan without undue reliance on incremental funding from the capital markets.

     

In the coming quarters, your Board and management team intend to maintain focus on accelerating Zevra's momentum – continuing to drive value for both rare disease patients and our stockholders.

Your Board and Management Team Have a Clear Path Forward to Continue Zevra's Momentum

Looking ahead, we have a clear strategic plan and path forward to continue Zevra's growth trajectory and realize our bright future. Our priorities in the coming year include:

  • Expanding adoption of MIPLYFFA. We are actively focused on increasing awareness and adoption of MIPLYFFA. Most recently, in February 2025, we launched efforts to provide integral educational and testing resources to NPC treatment teams and physicians in the U.S. Our market access team is also working tirelessly to continuously engage with payors to formalize coverage so that all patients may have access to this life-changing treatment.
  • Securing regulatory approval of MIPLYFFA in the EU. We remain on track to file a marketing authorization application (MAA) in the second half of 2025. This approval would further expand our addressable market to the estimated 1,100 people living with NPC in the EU.
  • Expanding adoption of OLPRUVA for the adult-onset population for whom OLPRUVA's portability and ease of administration may be most beneficial. Our efforts are also focused on supporting patients facing insurance coverage challenges.
  • Accelerating enrollment in the Phase 3 DiSCOVER trial for celiprolol, by expanding our outreach and education efforts within the patient community and among treating physicians. Accelerating enrollment and completion of the Phase 3 trial will advance efforts towards making this potential treatment available. There are currently no treatments approved in the U.S. for VEDS and the approximately 7,500 people living with this disease.

With a strong pipeline of innovative products, multiple upcoming milestones in the coming quarters, and your management team's continued disciplined execution, we are confident that Zevra is positioned for long-term success.