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Eton Pharmaceuticals Inc (ETON)
NASDAQ:ETON
US Market
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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
▲(3.53% 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
Product Development
ET-600, if approved, will be the only FDA-approved oral liquid formulation of desmopressin, positioning the company for a unique market advantage.
Product Expansion
Increlex has seen a significant increase in patient adoption since its relaunch, with potential for substantial market growth through label expansion.
Revenue Growth
The company continues to maintain its quarterly revenue growth trajectory with $18.9M, driven by strong performance from Alinkdi Sprinkle and the relaunches of Increlex and Galzin.
Negative Factors
Market Competition
ET-600 faces potential competition risks which could impact its market entry and success despite being a unique formulation.
Risks and Challenges
Risks to the Buy rating include clinical, commercial, collaboration, dilution, legal and intellectual property, and competition.

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: |
Next Earnings Date:Nov 12, 2025
Earnings Call Sentiment Positive
The earnings call presented a positive outlook with several major achievements in product sales, FDA approvals, and financial performance, despite some challenges related to product labeling and regulatory hurdles.
Q2-2025 Updates
Positive Updates
Record Product Sales and Revenue Growth
The company achieved record product sales with more than 100% revenue growth year-over-year, and revenue for Q2 2025 was $18.9 million, a 108% increase over the prior year period.
Strong Performance of Increlex
The relaunch of Increlex exceeded expectations, reaching 100 active patients months ahead of schedule, with a goal now set to reach 110 patients by the end of the year.
FDA Approval of Khindivi
Khindivi received FDA approval and was launched within days, addressing a critical unmet need in pediatric endocrinology.
ET-600 NDA Submission
The NDA for ET-600 was submitted and accepted for review, with a PDUFA date set for February 2026.
Financial Performance and Cash Flow
The company generated $8 million of cash flow from operations and achieved $3.1 million of adjusted EBITDA, demonstrating strong financial performance and profitability.
Negative Updates
Label Limitation for Khindivi
Khindivi was approved with a label for patients aged 5 and above, which limits its market potential as 60% of Alkindi patients are 4 and under.
Challenges in Harmonizing IGF-1 Definitions
Efforts to harmonize the U.S. and EU definitions of severe primary IGF-1 deficiency face potential challenges, requiring a follow-on clinical study for FDA approval.
Company Guidance
During the Eton Pharmaceuticals Q2 2025 earnings call, CEO Sean Brynjelsen highlighted several key achievements and future prospects. The company reported a record revenue of $18.9 million for the quarter, marking a 108% increase year-over-year, driven by product sales, particularly of Alkindi Sprinkle, Increlex, and Galzin. Eton anticipates reaching an $80 million annual revenue run rate by Q3 2025, three months ahead of schedule. The relaunches of Increlex and Galzin have significantly contributed to this growth, with Increlex patient numbers surpassing expectations. The FDA's approval of Khindivi, with a subsequent launch, and the NDA submission for ET-600, with a February 2026 PDUFA date, were also major milestones. Financially, the company generated $8 million in operating cash flow and $3.1 million in adjusted EBITDA, maintaining a strong cash position of over $30 million post-Q2. Looking ahead, Eton plans to expand its product portfolio, with ongoing efforts to address the unmet needs in pediatric endocrinology and ultra-rare diseases.

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 Price17.87
Price Trends
50DMA
15.48
Positive
100DMA
15.98
Positive
200DMA
14.94
Positive
Market Momentum
MACD
0.53
Negative
RSI
62.34
Neutral
STOCH
76.13
Neutral
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 17.87 is above the 20-day moving average (MA) of 16.87, above the 50-day MA of 15.48, and above the 200-day MA of 14.94, indicating a bullish trend. The MACD of 0.53 indicates Negative momentum. The RSI at 62.34 is Neutral, neither overbought nor oversold. The STOCH value of 76.13 is Neutral, 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 (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
66
Neutral
$460.99M-22.06%85.40%40.95%
59
Neutral
$460.69M-62.49%74.95%34.25%
51
Neutral
$7.91B-0.36-41.70%2.23%23.45%-1.86%
49
Neutral
$448.68M-34.97%-100.00%-61.86%
46
Neutral
$349.88M-57.39%27.32%-1.34%
42
Neutral
$311.56M-29.32%71.85%
38
Underperform
$489.46M-56.28%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ETON
Eton Pharmaceuticals
17.87
13.28
289.32%
RGNX
RegenXBio
9.42
-2.06
-17.94%
TECX
Tectonic Therapeutic
17.27
-1.09
-5.94%
ITOS
iTeos Therapeutics
10.15
-4.65
-31.42%
ABSI
AbSci
2.40
-1.62
-40.30%
MBX
MBX Biosciences, Inc.
12.92
-8.73
-40.32%

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