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Eton Pharmaceuticals Inc (ETON)
NASDAQ:ETON
US Market

Eton Pharmaceuticals (ETON) AI Stock Analysis

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ETON

Eton Pharmaceuticals

(NASDAQ:ETON)

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Neutral 64 (OpenAI - 5.2)
Rating:64Neutral
Price Target:
$16.00
▼(-5.83% Downside)
Action:ReiteratedDate:02/02/26
ETON scores as moderately attractive primarily due to improving fundamentals—strong revenue acceleration, robust operating/free cash flow, and a de-risked balance sheet—supported by a generally positive earnings-call outlook on growth and margins. The score is held back by weak technical trends and the lack of current profitability (negative earnings and net losses), with valuation less supportive due to negative EPS and no dividend yield.
Positive Factors
Revenue Momentum
Sustained top-line acceleration to TTM $70.3M and 19 consecutive quarters of sequential growth indicate durable commercial traction. A multi-product mix (ALKINDI, Carglumic Acid, INCRELEX, GALZIN) shows scalable sales execution and repeatable demand across niche pediatric and rare-disease channels.
Cash Generation
Robust operating and free cash flow in the TTM period reflects a structural shift to positive cash-generation after prior years of outflows. This enhances funding flexibility for launches, BD, and label studies without sizable external financing, strengthening long-term operational independence.
De-risked Balance Sheet
Significantly lower leverage vs. prior periods materially reduces financial risk and interest burden. A healthier capital structure supports continued M&A and licensing activity, and gives management runway to commercialize ultra-rare assets while limiting refinancing pressure.
Negative Factors
Persistent Losses
Despite revenue and cash-flow gains, the company remains unprofitable on a net income basis in the TTM. Continued losses constrain return metrics and could limit ability to sustainably invest in marketing or R&D without dilutive financing if cash generation weakens.
Regulatory Label Restriction
An FDA age-based restriction on KHINDIVI structurally reduces addressable market in the largest unmet pediatric cohort. Expanding the label will require additional safety data or reformulation, delaying revenue expansion and adding clinical and commercial execution risk over multiple quarters.
Narrow Patient Dynamics (INCRELEX)
Flat active patient counts and aging-out dynamics create a structural ceiling on organic growth for INCRELEX absent label expansion or new indications. Reliance on small, churn-prone patient populations increases revenue volatility and raises the bar for successful BD or label-harmonization efforts.

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

Eton Pharmaceuticals Business Overview & Revenue Model

Company DescriptionEton Pharmaceuticals, Inc., a specialty pharmaceutical company, focuses on developing and commercializing pharmaceutical products for rare diseases. The company offers Biorphen, a phenylephrine injection for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia; Carglumic Acid for the treatment of acute and chronic hyperammonemia due to N-acetylglutamate Synthase deficiency; and Rezipres, a ready-to-use formulation of a molecule that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. It also offers Alkindi Sprinkle, a replacement therapy for adrenocortical insufficiency in children under 17 years of age; EPRONTIA, a liquid formulation of topiramate; and Alaway Preservative Free, a preservative-free ophthalmic product to treat allergic conjunctivitis. In addition, the company develops Zonisamide Oral Suspension for the treatment of partial on-set seizures; Lamotrigine for Oral Suspension for the treatment of partial on-set seizures; cysteine injection; dehydrated alcohol injection; and Zeneo hydrocortisone autoinjector. Eton Pharmaceuticals, Inc. was incorporated in 2017 and is based in Deer Park, Illinois.
How the Company Makes MoneyEton Pharmaceuticals generates revenue primarily through the commercialization of its pharmaceutical products. The company earns income by selling its developed medications directly to healthcare providers, pharmacies, and hospitals. Additionally, Eton may receive milestone payments and royalties from licensing agreements with larger pharmaceutical companies, which partner with Eton to develop and distribute specific products. These partnerships often involve shared responsibilities in development and marketing, allowing Eton to leverage the resources and networks of its partners. Furthermore, the company may benefit from government contracts and grants aimed at supporting the development of pediatric formulations, contributing to its overall revenue stream.

Eton Pharmaceuticals Earnings Call Summary

Earnings Call Date:Nov 06, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 12, 2026
Earnings Call Sentiment Positive
Eton Pharmaceuticals experienced substantial revenue growth and strong performance from key products, leading to positive cash flow generation and profitability. However, the company faced challenges with net income, patient count for INCRELEX, and FDA restrictions on KHINDIVI. Despite these challenges, the overall outlook remains positive with strategic initiatives underway.
Q3-2025 Updates
Positive Updates
Record Revenue Growth
Eton Pharmaceuticals reported third-quarter product revenue of $22.5 million, representing an increase of 129% year-over-year and 19% from the second quarter. This marks the 19th consecutive quarter of sequential product revenue growth.
Strong Performance of Key Products
ALKINDI SPRINKLE and Carglumic Acid contributed significantly to revenue growth, with new patient additions boosting sales. INCRELEX and GALZIN, recently acquired products, are also performing ahead of projections.
Cash Generation and Profitability
Eton Pharmaceuticals generated $12 million in cash from operations and reported an adjusted EBITDA of $2.9 million. Operating expenses were controlled, resulting in a reduction in adjusted SG&A expense from the second to the third quarter.
Successful Product Launches and Developments
The company successfully launched three high-value commercial products and submitted an NDA for ET-600. Eton also plans to expand the market for INCRELEX through harmonization of labels in the U.S. and EU.
Negative Updates
Net Loss Reported
Eton Pharmaceuticals reported a net loss of $1.9 million for the quarter, compared to net income of $0.6 million in the prior year period.
INCRELEX Patient Count Challenges
While INCRELEX revenue and patient count exceeded projections, the net active patient count remained flat due to a high number of patients aging out of treatment.
KHINDIVI Label Restriction
The FDA restricted KHINDIVI for patients under 5 years old due to limited safety data on certain inactive ingredients, affecting adoption rates among the largest unmet need demographic.
Lower Revenue Per INCRELEX Patient
The third quarter saw a less favorable payer mix for INCRELEX, resulting in lower revenue per patient compared to the second quarter.
Company Guidance
During the Eton Pharmaceuticals Third Quarter 2025 Financial Results Conference Call, the company reported a robust 129% year-over-year increase in third-quarter product revenue to $22.5 million, marking their 19th consecutive quarter of sequential revenue growth. Key growth drivers included ALKINDI SPRINKLE and Carglumic Acid, alongside newly acquired products INCRELEX and GALZIN. The company also generated $12 million in cash from operations during the quarter. They reported an adjusted EBITDA of $2.9 million, influenced by nonrecurring costs related to INCRELEX's ex-U.S. transition. Eton Pharmaceuticals aims for significant margin expansion, with expectations to achieve a 70% adjusted gross margin in the upcoming quarter. The CEO highlighted ongoing efforts to expand their market reach, including initiatives to harmonize the INCRELEX label between the U.S. and the EU and plans to conduct a bioequivalency study for KHINDIVI to potentially expand its label. The company also emphasized their commitment to business development, exploring opportunities to acquire additional products in strategically aligned ultra-rare disease markets.

Eton Pharmaceuticals Financial Statement Overview

Summary
Financials are trending positively with rapid revenue growth (TTM $70.3M) and strong cash generation (TTM operating cash flow $21.3M; free cash flow $21.0M). Balance sheet risk has improved with low TTM debt ($3.3M) versus equity ($23.1M), but net income remains negative in TTM (-$6.7M), keeping profitability as the key overhang.
Income Statement
62
Positive
ETON shows strong top-line momentum, with revenue accelerating from $21.3M (2022) to $31.6M (2023) to $39.0M (2024) and $70.3M in TTM (Trailing-Twelve-Months), supported by solid gross profitability (about 51% gross margin in TTM). However, profitability remains the key overhang: net income is still negative in TTM (-$6.7M) and operating profit is slightly negative, indicating the business has not yet consistently converted growth into sustainable earnings despite meaningful improvement versus earlier years.
Balance Sheet
68
Positive
Leverage and capitalization look improved in the most recent period: total debt is low in TTM ($3.3M) relative to equity ($23.1M), which reduces financial risk versus 2024 when debt was much higher ($29.9M) and leverage was elevated. The main weakness is that shareholder returns are still negative due to ongoing losses (negative return on equity in both TTM and prior years), so the balance sheet is healthier but not yet being paired with consistent profitability.
Cash Flow
78
Positive
Cash generation is a clear strength. In TTM (Trailing-Twelve-Months), operating cash flow is robust ($21.3M) and free cash flow is similarly strong ($21.0M) with significant free-cash-flow growth versus the prior period, indicating improved cash efficiency and funding flexibility. The key watch item is that profits are still negative, so cash flow strength may reflect favorable working-capital timing or other non-earnings factors; still, the multi-year trend shows a material shift from negative cash flow in 2020–2021 to sustained positive levels in 2022–TTM.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue70.32M39.01M31.64M21.25M21.83M39.00K
Gross Profit36.12M23.41M21.06M14.32M19.21M-247.00K
EBITDA1.32M-1.45M-291.00K-6.49M-1.03M-26.46M
Net Income-6.68M-3.82M-936.00K-9.02M-1.96M-27.97M
Balance Sheet
Total Assets104.51M76.12M31.74M25.03M27.46M26.32M
Cash, Cash Equivalents and Short-Term Investments37.12M14.94M21.39M16.30M14.41M21.30M
Total Debt3.26M29.92M5.40M6.52M6.70M7.14M
Total Liabilities81.38M51.70M16.26M11.95M9.84M10.66M
Stockholders Equity23.13M24.43M15.48M13.08M17.63M15.66M
Cash Flow
Free Cash Flow21.01M943.00K6.04M2.03M-7.98M-22.40M
Operating Cash Flow21.31M969.00K6.82M4.82M-4.72M-22.35M
Investing Cash Flow-38.42M-40.01M-775.00K-2.79M-2.56M-50.00K
Financing Cash Flow33.97M32.59M-957.00K-134.00K391.00K31.63M

Eton Pharmaceuticals Technical Analysis

Technical Analysis Sentiment
Positive
Last Price16.99
Price Trends
50DMA
16.13
Positive
100DMA
16.91
Positive
200DMA
16.82
Positive
Market Momentum
MACD
0.55
Negative
RSI
54.28
Neutral
STOCH
24.32
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 16.99 is above the 20-day moving average (MA) of 16.42, above the 50-day MA of 16.13, and above the 200-day MA of 16.82, indicating a bullish trend. The MACD of 0.55 indicates Negative momentum. The RSI at 54.28 is Neutral, neither overbought nor oversold. The STOCH value of 24.32 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
64
Neutral
$455.63M-68.21-34.17%102.77%-17.00%
60
Neutral
$1.46B-13.60-24.43%-44.79%
57
Neutral
$440.31M-5.80-32.21%60.40%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
47
Neutral
$457.63M-2.59-76.88%91.30%30.69%
46
Neutral
$412.02M-3.03-55.68%-33.09%3.38%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ETON
Eton Pharmaceuticals
16.99
1.29
8.22%
RGNX
RegenXBio
9.04
2.47
37.60%
TECX
Tectonic Therapeutic
23.45
-1.83
-7.24%
ABSI
AbSci
2.74
-1.11
-28.83%
MBX
MBX Biosciences, Inc.
32.55
22.95
239.06%

Eton Pharmaceuticals Corporate Events

Business Operations and StrategyProduct-Related Announcements
Eton Pharmaceuticals Licenses U.S. Rights to Ultra-Rare Drug
Positive
Feb 2, 2026

On February 2, 2026, Eton Pharmaceuticals announced it had licensed U.S. marketing rights to an ultra-rare disease product candidate that, once approved, is expected to become the first and only generic alternative to a treatment for a condition affecting fewer than 100 patients nationwide. The asset, currently under FDA review and targeted for a mid-2026 approval and launch, is intended to leverage Eton’s existing commercial infrastructure and Eton Cares patient support program, adding to its projected 2026 product launches and supporting the company’s strategy to build one of the largest ultra-rare disease portfolios, which may further entrench its position in the highly specialized orphan drug market and offer a potentially improved experience for a very small but underserved patient population.

The most recent analyst rating on (ETON) stock is a Hold with a $17.00 price target. To see the full list of analyst forecasts on Eton Pharmaceuticals stock, see the ETON Stock Forecast page.

Business Operations and Strategy
Eton Pharmaceuticals Joins Piper Sandler Healthcare Conference
Neutral
Dec 4, 2025

On December 4, 2025, Eton Pharmaceuticals, Inc. management will attend the Piper Sandler Annual Healthcare Conference in New York, presenting their corporate slide presentation. This participation is part of their engagement with investors and stakeholders, potentially impacting their market presence and investor relations.

The most recent analyst rating on (ETON) stock is a Buy with a $35.00 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: Feb 02, 2026