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Zevra Therapeutics (ZVRA)
NASDAQ:ZVRA

Zevra Therapeutics (ZVRA) AI Stock Analysis

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Zevra Therapeutics

(NASDAQ:ZVRA)

Rating:54Neutral
Price Target:
$9.00
▲(5.26%Upside)
Zevra Therapeutics' overall score is primarily influenced by strong revenue growth but is hampered by significant profitability and leverage issues. Technical indicators show positive momentum, yet caution is advised due to potential overbought conditions. The valuation remains challenging with ongoing losses, and while the earnings call highlighted strategic progress, market penetration challenges persist.
Positive Factors
FDA approval
FDA approval of Miplyffa for Niemann-Pick disease type C marked the first FDA-approved therapy for NPC.
Financial performance
Zevra reported net revenue of $20.4M, beating consensus and forecast, with Miplyffa generating $17.1M in net revenue.
Negative Factors
Olpruva performance
Olpruva's revenue remains modest despite a strategy focused on targeting adult patients with reimbursement challenges.
Patient adoption data
ZVRA did not provide a specific number to our question on how many patients are on the product and what fraction might be 'paid patients'.

Zevra Therapeutics (ZVRA) vs. SPDR S&P 500 ETF (SPY)

Zevra Therapeutics Business Overview & Revenue Model

Company DescriptionZevra Therapeutics, Inc., a rare disease company melding science, discovers and develops various proprietary prodrugs to treat serious medical conditions in the United States. The company utilizes its Ligand Activated Therapy technology to generate improved prodrug versions of FDA-approved drugs, as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. Its prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, stimulant use disorder, and CNS rare diseases, including idiopathic hypersomnia (IH). The company's lead product candidate KP1077, which is under Phase II clinical trial for the treatment of IH and narcolepsy, is based on its prodrug of d-methylphenidate, known as serdexmethylphenidate. It is also developing KP879, a prodrug product candidate for the treatment of stimulant use disorder and is under Phase II clinical trial. In addition, the company has received FDA approval for AZSTARYS, a once-daily treatment for attention deficit hyperactivity disorder in patents age six years and older, and for APADAZ, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. The company's product pipeline include, arimoclomol It has collaboration and license agreement with KVK-Tech, Inc. and Commave Therapeutics SA. The company was formerly known as KemPharm, Inc. and changed its name to Zevra Therapeutics, Inc. in February 2023. Zevra Therapeutics, Inc. was incorporated in 2006 and is headquartered in Celebration, Florida.
How the Company Makes MoneyZevra Therapeutics makes money through a revenue model centered on the development and commercialization of its proprietary drug candidates. The company generates revenue primarily through the sale of its approved therapies and milestone payments from collaboration and licensing agreements with other pharmaceutical companies. Additionally, Zevra Therapeutics may receive royalty payments based on sales of its licensed products. Strategic partnerships and collaborations play a significant role in the company's earnings, providing additional funding for research and development, as well as expanding the reach of its products in global markets.

Zevra Therapeutics Earnings Call Summary

Earnings Call Date:May 13, 2025
(Q1-2025)
|
% Change Since: 8.64%|
Next Earnings Date:Aug 19, 2025
Earnings Call Sentiment Positive
The earnings call highlighted strong performance and strategic progress, especially with the successful launch of MIPLYFFA and robust financial positioning. However, challenges remain with OLPRUVA's market penetration and limited initial market access for MIPLYFFA.
Q1-2025 Updates
Positive Updates
Successful Launch of MIPLYFFA
Exceeded internal expectations for MIPLYFFA with over one-third of diagnosed Niemann-Pick disease type C (NPC) patients in the U.S. enrolled. Received 122 prescription enrollment forms by March 31, 2025, with 13 in Q1 2025.
Expansion Plans for MIPLYFFA
Plans to expand availability of MIPLYFFA outside the U.S. with a marketing authorization application in Europe in the second half of 2025, targeting approximately 1100 people living with NPC.
Financial Strength and Flexibility
Monetization of pediatric rare disease priority review voucher added $148.3 million of non-dilutive capital to the balance sheet, increasing total cash, cash equivalents, and investments to $217 million.
Recognition of Innovation
Earned a spot on Fast Company's top 10 most innovative companies list in the medicines, therapeutics, and pharmaceuticals category.
Pipeline Progress with Celiprolol
Phase 3 Discover trial for Celiprolol continues to progress with 32 patients enrolled for vascular Ehlers-Danlos syndrome (VEDS).
Negative Updates
OLPRUVA Launch Challenges
Received a total of 28 prescription enrollment forms since July 2023, indicating moderate expectations due to the unique dynamics of the UCD commercial landscape and fewer reimbursements.
Limited Market Access for MIPLYFFA
As of the end of Q1 2025, only 38% of covered lives have formalized reimbursement policies for MIPLYFFA, creating potential barriers to access.
R&D Expense Reduction
R&D expenses decreased by 9% compared to Q1 2024 due to the completion of the KP1077 Phase 2 trial and reduced personnel-related costs, potentially indicating a reduction in R&D activities.
Company Guidance
During Zevra's First Quarter 2025 Financial Results and Corporate Update Conference Call, the company provided various metrics reflecting its strategic progress. Zevra announced that for its newly launched product MIPLYFFA, aimed at Niemann-Pick disease type C (NPC), it had received 122 prescription enrollment forms by March 31, 2025, with 13 forms in the first quarter alone. Approximately 38% of covered lives have been secured for MIPLYFFA, aligning with the company's expectations at this stage. Additionally, Zevra's other product, OLPRUVA, received a total of 28 prescription enrollment forms since its promotion began in January 2024, including 5 forms in the first quarter of 2025. Financially, Zevra reported a net revenue of $20.4 million for Q1 2025, with $17.1 million attributed to MIPLYFFA. The company's strategic focus includes advancing their Phase 3 Discover trial for Celiprolol and aiming to extend MIPLYFFA's availability beyond the U.S., with an MAA submission planned in Europe, where approximately 1,100 people are estimated to be living with NPC.

Zevra Therapeutics Financial Statement Overview

Summary
Zevra Therapeutics shows strong revenue growth; however, it struggles with profitability and high leverage. The negative net profit and EBIT margins, coupled with a high debt-to-equity ratio and substantial cash outflows, highlight significant financial challenges.
Income Statement
45
Neutral
The company exhibited a strong revenue growth rate of 71.86% TTM (Trailing-Twelve-Months), indicating robust top-line expansion. However, it faces challenges with profitability, as evidenced by a negative net profit margin of -226.67% TTM and a negative EBIT margin of -177.09% TTM. These negative margins reflect significant operational and financial hurdles in achieving profitability.
Balance Sheet
40
Negative
The debt-to-equity ratio stands at 1.51 TTM, signaling a high leverage position which could pose financial risks. The company's equity ratio of 23.76% TTM is relatively low, indicating a reliance on debt financing. Additionally, the return on equity (ROE) is negative at -224.26% TTM, reflecting substantial losses relative to shareholder equity.
Cash Flow
30
Negative
The free cash flow is negative at -$61.82 million TTM, with a free cash flow growth rate of 11.26%, suggesting moderate improvement. The operating cash flow to net income ratio is 0.67 TTM, indicating some alignment between operational performance and reported earnings, albeit with negative cash flow.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
40.59M23.61M27.46M10.46M28.65M13.29M
Gross Profit
32.00M16.20M24.52M10.12M26.59M11.98M
EBIT
-71.88M-87.00M-49.60M-24.84M7.73M-4.78M
EBITDA
-67.37M-76.40M-48.60M-25.53M-7.89M-5.43M
Net Income Common Stockholders
-91.99M-105.51M-46.05M-41.54M-8.55M-12.76M
Balance SheetCash, Cash Equivalents and Short-Term Investments
37.34M69.50M43.05M82.85M112.35M4.21M
Total Assets
172.71M178.13M172.33M115.53M132.94M11.21M
Total Debt
61.84M60.30M43.77M14.12M1.59M70.35M
Net Debt
24.50M26.51M716.00K-51.34M-110.76M66.14M
Total Liabilities
131.69M138.46M110.46M29.72M5.82M77.62M
Stockholders Equity
41.02M39.67M61.86M85.81M127.12M-66.41M
Cash FlowFree Cash Flow
-61.82M-69.67M-33.83M-18.81M10.34M-1.97M
Operating Cash Flow
-61.72M-69.67M-33.53M-18.72M10.44M-1.94M
Investing Cash Flow
-26.41M-22.16M-17.39M-36.72M-15.52M-33.00K
Financing Cash Flow
82.50M82.11M28.46M8.35M113.11M2.74M

Zevra Therapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price8.55
Price Trends
50DMA
7.70
Positive
100DMA
7.81
Positive
200DMA
7.98
Positive
Market Momentum
MACD
0.28
Negative
RSI
59.19
Neutral
STOCH
49.58
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ZVRA, the sentiment is Positive. The current price of 8.55 is above the 20-day moving average (MA) of 8.24, above the 50-day MA of 7.70, and above the 200-day MA of 7.98, indicating a bullish trend. The MACD of 0.28 indicates Negative momentum. The RSI at 59.19 is Neutral, neither overbought nor oversold. The STOCH value of 49.58 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for ZVRA.

Zevra Therapeutics Risk Analysis

Zevra Therapeutics disclosed 62 risk factors in its most recent earnings report. Zevra Therapeutics reported the most risks in the “Tech & Innovation” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 3 New Risks
1.
If commercialization of our approved products, or any of our product candidates, if approved, are not successful, or we experience significant delays in commercialization, our business will be harmed. Q4, 2024
2.
We are subject to complex and changing laws and regulations, which exposes us to potential liabilities, increased costs and other adverse effects on our business. Q4, 2024
3.
Because the target patient population for certain of our products is small, we must achieve significant market share and obtain relatively high per-patient prices for our products to achieve meaningful gross margins. Q4, 2024

Zevra Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (53)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
59
Neutral
$533.01M
54
Neutral
$467.51M-204.78%44.92%-40.06%
53
Neutral
$5.22B3.32-45.04%2.83%16.81%-0.27%
UPUPB
48
Neutral
$502.97M
44
Neutral
$528.05M-45.46%-78.26%15.41%
40
Underperform
$194.53M87.26%-43.76%
$622.60M
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ZVRA
Zevra Therapeutics
8.55
3.67
75.20%
OMER
Omeros
3.09
-0.97
-23.89%
RLAY
Relay Therapeutics
3.00
-3.79
-55.82%
UPB
Upstream Bio, Inc.
9.23
-14.15
-60.52%
MAZE
Maze Therapeutics, Inc.
10.01
-4.99
-33.27%
SION
Sionna Therapeutics, Inc.
13.69
-8.55
-38.44%

Zevra Therapeutics Corporate Events

Executive/Board ChangesShareholder Meetings
Zevra Therapeutics Elects New Directors at Annual Meeting
Neutral
May 29, 2025

On May 29, 2025, Zevra Therapeutics held its Annual Meeting of Stockholders where Wendy Dixon, Ph.D., and Tamara A. Favorito were elected as directors. The meeting also saw the ratification of Ernst & Young LLP as the independent public accounting firm for the fiscal year ending December 31, 2025. The election process was marked by the disqualification of nominees proposed by stockholder Daniel J. Mangless due to non-compliance with legal requirements and company bylaws, ensuring the election of the company’s preferred candidates.

The most recent analyst rating on (ZVRA) stock is a Buy with a $20.00 price target. To see the full list of analyst forecasts on Zevra Therapeutics stock, see the ZVRA Stock Forecast page.

Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.