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Eton Pharmaceuticals Inc (ETON)
NASDAQ:ETON
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Eton Pharmaceuticals (ETON) AI Stock Analysis

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ETON

Eton Pharmaceuticals

(NASDAQ:ETON)

Rating:66Neutral
Price Target:
$18.50
▲(10.78% Upside)
Eton Pharmaceuticals' overall score is driven by strong technical indicators and positive earnings call outcomes, indicating potential growth. However, financial performance and valuation concerns, particularly profitability issues and a negative P/E ratio, temper the outlook.
Positive Factors
FDA Approval
Khindivi received FDA approval as a replacement therapy for pediatric patients with adrenal insufficiency, potentially becoming the hydrocortisone formulation of choice.
Product Expansion
If Increlex receives a new label expanding the eligible population, the peak revenue potential could grow five-fold to nearly $300M.
Revenue Growth
The company maintains its quarterly revenue growth trajectory with a notable performance of $18.9M for 2Q25, driven by strong sales from Alinkdi Sprinkle and the relaunches of Increlex and Galzin.
Negative Factors
Market Risks
Risks to the Buy rating include clinical, commercial, collaboration, dilution, legal and intellectual property, and competition.
Regulatory Approval
ET-400 is pending a positive decision from the FDA, which could impact future revenue if not approved as expected.

Eton Pharmaceuticals (ETON) vs. SPDR S&P 500 ETF (SPY)

Eton Pharmaceuticals Business Overview & Revenue Model

Company DescriptionEton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative pharmaceutical products, primarily in the areas of pediatrics and rare diseases. The company's portfolio includes approved products, as well as a robust pipeline of product candidates that leverage its proprietary formulations and delivery technologies. Eton aims to address unmet medical needs by providing medications that are safer, more effective, and easier to administer for patients, particularly in underserved populations.
How the Company Makes MoneyEton Pharmaceuticals generates revenue primarily through the sale of its pharmaceutical products, which include both approved medications and those in various stages of development. The company earns revenue from product sales, including both direct sales and sales through partnerships with other pharmaceutical companies. Additionally, Eton may receive milestone payments and royalty income from its collaborations and licensing agreements. These partnerships often involve sharing development costs and risks, allowing Eton to leverage its resources effectively. The company also benefits from government programs and incentives aimed at promoting the development of treatments for rare diseases and pediatric conditions, which can further enhance its financial performance.

Eton Pharmaceuticals Earnings Call Summary

Earnings Call Date:Aug 07, 2025
(Q2-2025)
|
% Change Since: 9.44%|
Next Earnings Date:Nov 12, 2025
Earnings Call Sentiment Positive
Eton Pharmaceuticals demonstrated strong revenue growth and successful product launches, particularly with Increlex and Galzin. Financial performance was solid with significant cash flow and EBITDA gains. However, Khindivi's limited age approval and the need for further clinical studies for Increlex present challenges that could affect future growth.
Q2-2025 Updates
Positive Updates
Record Revenue Growth
Eton Pharmaceuticals reported Q2 2025 revenue of $18.9 million, a 108% increase from the same period in 2024, driven by product sales from Alkindi, Increlex, and Galzin.
Strong Product Launches
The company successfully relaunched Increlex and Galzin, leading to record product sales and more than 100% revenue growth year-over-year. FDA approval and immediate launch of Khindivi also marked a significant milestone.
Positive Financial Performance
Eton generated $8 million in cash flow from operations and achieved $3.1 million in adjusted EBITDA. The company also has over $30 million in cash on hand.
Accelerated Revenue Projections
Eton now anticipates reaching an $80 million annual revenue run rate in Q3 2025, three months earlier than previously projected.
Negative Updates
Khindivi's Limited Approval
Khindivi was approved for patients aged 5 and older, limiting its market potential as 60% of Alkindi patients are 4 and under. Efforts are underway to broaden the label, but this presents a near-term challenge.
Clinical Study Requirement for Increlex
The FDA has requested a follow-on clinical study to harmonize U.S. and EU definitions of severe primary IGF-1 deficiency, which could impact Increlex's market expansion.
Company Guidance
During Eton Pharmaceuticals' Q2 2025 earnings call, the company provided robust guidance, indicating a significant growth trajectory. Eton reported a 108% year-over-year revenue increase, reaching $18.9 million, driven by strong performances from Alkindi Sprinkle, Increlex, and Galzin. The company now anticipates achieving an $80 million annual revenue run rate by Q3 2025, three months ahead of schedule. Increlex exceeded expectations by reaching 100 active patients five months early, and Eton aims for 110 patients by year-end. The launch of Khindivi, approved on May 28, fulfills a critical unmet need, although its current label limits pediatric use to those five years and older. Eton plans to address this with a revised formulation expected for FDA submission in the first half of 2026. The company also highlighted a strategic focus on expanding market opportunities, including potential harmonization of severe primary IGF-1 deficiency definitions between the U.S. and EU, which could expand Increlex's market from $60 million to $300 million annually. Furthermore, Eton generated $8 million in operating cash flow and reported $3.1 million in adjusted EBITDA, emphasizing their commitment to profitability and future acquisitions.

Eton Pharmaceuticals Financial Statement Overview

Summary
Eton Pharmaceuticals shows promising revenue growth but struggles with profitability. Balance sheet stability is supported by low leverage, yet the high liabilities are a risk. Cash flow management has improved, but further efforts are needed to convert earnings into cash.
Income Statement
60
Neutral
Eton Pharmaceuticals has shown significant revenue growth, with a notable increase from $21.3 million in 2022 to $39 million in 2024. However, profitability remains a concern as indicated by negative EBIT and net income, which suggests challenges in cost management or market competition.
Balance Sheet
55
Neutral
The balance sheet reveals a relatively stable equity base, with stockholders' equity increasing to $24.4 million in 2024. The debt-to-equity ratio is low, indicating low leverage, but the company faces high liabilities compared to assets, which may impact future financial flexibility.
Cash Flow
65
Positive
Positive free cash flow in 2024, at $943,000, marks an improvement compared to previous years, suggesting better cash management. However, the operating cash flow to net income ratio is low, indicating that net income is not translating effectively into cash flow.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue58.18M39.01M31.64M21.25M21.83M39.00K
Gross Profit34.56M23.41M21.06M14.32M19.21M-247.00K
EBITDA19.00K-1.45M-291.00K-6.49M-1.12M-26.46M
Net Income-4.13M-3.82M-936.00K-9.02M-1.96M-27.97M
Balance Sheet
Total Assets101.68M76.12M31.74M25.03M27.46M26.32M
Cash, Cash Equivalents and Short-Term Investments25.38M14.94M21.39M16.30M14.41M21.30M
Total Debt3.26M29.92M5.40M6.52M6.70M7.14M
Total Liabilities77.72M51.70M16.26M11.95M9.84M10.66M
Stockholders Equity23.96M24.43M15.48M13.08M17.63M15.66M
Cash Flow
Free Cash Flow5.97M943.00K6.04M2.03M-7.98M-22.40M
Operating Cash Flow12.24M969.00K6.82M4.82M-4.72M-22.35M
Investing Cash Flow-38.13M-40.01M-775.00K-2.79M-2.56M-50.00K
Financing Cash Flow33.58M32.59M-957.00K-134.00K391.00K31.63M

Eton Pharmaceuticals Technical Analysis

Technical Analysis Sentiment
Positive
Last Price16.70
Price Trends
50DMA
14.95
Positive
100DMA
15.45
Positive
200DMA
14.40
Positive
Market Momentum
MACD
0.53
Negative
RSI
61.78
Neutral
STOCH
86.45
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ETON, the sentiment is Positive. The current price of 16.7 is above the 20-day moving average (MA) of 15.37, above the 50-day MA of 14.95, and above the 200-day MA of 14.40, indicating a bullish trend. The MACD of 0.53 indicates Negative momentum. The RSI at 61.78 is Neutral, neither overbought nor oversold. The STOCH value of 86.45 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for ETON.

Eton Pharmaceuticals Risk Analysis

Eton Pharmaceuticals disclosed 45 risk factors in its most recent earnings report. Eton Pharmaceuticals reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Eton Pharmaceuticals Peers Comparison

Overall Rating
UnderperformOutperform
Sector (47)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
66
Neutral
$464.48M-22.06%85.40%40.95%
52
Neutral
$409.17M-62.49%74.95%34.25%
51
Neutral
$428.36M-57.39%27.32%-1.34%
49
Neutral
$446.92M-34.97%-100.00%-61.86%
47
Neutral
C$212.79M-2.12-24.82%3.10%19.48%-0.09%
42
Neutral
$409.42M-29.32%71.85%
38
Underperform
$420.93M-56.28%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ETON
Eton Pharmaceuticals
16.70
12.69
316.46%
RGNX
RegenXBio
9.06
-3.35
-26.99%
TECX
Tectonic Therapeutic
24.47
7.57
44.79%
ITOS
iTeos Therapeutics
10.11
-5.30
-34.39%
ABSI
AbSci
3.00
-1.14
-27.54%
MBX
MBX Biosciences, Inc.
13.21
-8.44
-38.98%

Eton Pharmaceuticals Corporate Events

Product-Related Announcements
Eton Pharmaceuticals’ New Drug Application Accepted by FDA
Positive
Jul 8, 2025

On July 8, 2025, Eton Pharmaceuticals announced that its New Drug Application for ET-600, a patented desmopressin oral solution, was accepted for review by the FDA, with a target action date set for February 25, 2026. If approved, ET-600 will be the only oral liquid option for treating central diabetes insipidus in pediatric patients, addressing a significant unmet need and representing a potential high-value product launch for Eton in early 2026.

The most recent analyst rating on (ETON) stock is a Buy with a $24.00 price target. To see the full list of analyst forecasts on Eton Pharmaceuticals stock, see the ETON Stock Forecast page.

Delistings and Listing Changes
Eton Pharmaceuticals Joins Russell 3000 and 2000 Indexes
Positive
Jun 27, 2025

On June 27, 2025, Eton Pharmaceuticals announced its inclusion in the Russell 3000® and Russell 2000® Indexes, effective after the U.S. market close on the same day. This milestone highlights the company’s significant shareholder value generation over the past year and is expected to enhance its visibility among investors, potentially impacting its market positioning positively.

The most recent analyst rating on (ETON) stock is a Buy with a $24.00 price target. To see the full list of analyst forecasts on Eton Pharmaceuticals stock, see the ETON Stock Forecast page.

Executive/Board ChangesShareholder Meetings
Eton Pharmaceuticals Holds Annual Stockholders Meeting
Positive
Jun 10, 2025

On June 10, 2025, Eton Pharmaceuticals, Inc. held its Annual Meeting of Stockholders virtually. During the meeting, stockholders elected Paul V. Maier as a director for a three-year term and ratified Crowe LLP as the independent registered public accounting firm for the year ending December 31, 2025. These decisions are expected to influence the company’s governance and financial oversight positively.

The most recent analyst rating on (ETON) stock is a Buy with a $24.00 price target. To see the full list of analyst forecasts on Eton Pharmaceuticals stock, see the ETON Stock Forecast page.

Product-Related AnnouncementsBusiness Operations and Strategy
Eton Pharmaceuticals Gains FDA Approval for KHINDIVI
Positive
May 28, 2025

On May 28, 2025, Eton Pharmaceuticals announced the FDA approval of KHINDIVI, the first and only FDA-approved hydrocortisone oral solution for pediatric patients with adrenocortical insufficiency. This approval marks a significant advancement for patients and caregivers, offering a more precise and convenient dosing option. The commercial launch is expected in early June, with projected peak sales of KHINDIVI and ALKINDI SPRINKLE exceeding $50 million annually. The introduction of KHINDIVI is expected to enhance Eton’s market position in the rare disease treatment sector, providing a critical new tool for pediatric endocrinologists and improving treatment outcomes for patients.

The most recent analyst rating on (ETON) stock is a Buy with a $24.00 price target. To see the full list of analyst forecasts on Eton Pharmaceuticals stock, see the ETON Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

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.Date of analysis: Aug 12, 2025