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ANI Pharmaceuticals Inc (ANIP)
NASDAQ:ANIP

ANI Pharmaceuticals (ANIP) AI Stock Analysis

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ANIP

ANI Pharmaceuticals

(NASDAQ:ANIP)

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Neutral 66 (OpenAI - 5.2)
Rating:66Neutral
Price Target:
$88.00
▲(3.49% Upside)
The score is driven primarily by solid financial momentum (revenue and free-cash-flow growth) and very strong recent guidance-driven outlook from management, reinforced by positive preliminary results and 2026 outlook. These positives are tempered by ongoing profitability/ROE weakness, a technically mixed setup, and a high P/E valuation.
Positive Factors
Revenue Growth
Significant revenue growth indicates strong market demand and effective sales strategies, supporting long-term business expansion.
Cash Flow Improvement
Enhanced cash generation capabilities improve financial flexibility, enabling strategic investments and debt reduction.
Rare Disease Business Expansion
Strong growth in the Rare Disease segment, particularly Cortrophin Gel, positions ANI for sustained market leadership and revenue diversification.
Negative Factors
Profitability Challenges
Ongoing profitability issues may hinder reinvestment and shareholder returns, requiring strategic focus on cost management and margin improvement.
Generics Margin Pressure
Margin pressure in the Generics segment could impact overall profitability, necessitating efficiency improvements and cost control measures.
Return on Equity Concerns
Negative ROE indicates challenges in generating shareholder value, highlighting the need for strategic initiatives to enhance profitability.

ANI Pharmaceuticals (ANIP) vs. SPDR S&P 500 ETF (SPY)

ANI Pharmaceuticals Business Overview & Revenue Model

Company DescriptionANI Pharmaceuticals, Inc., a biopharmaceutical company, develops, manufactures, and markets branded and generic prescription pharmaceuticals in the United States and Canada. It focuses on producing controlled substances, oncology products, hormones and steroids, injectables, and other formulations. The company manufactures oral solid dose products; semi-solids, liquids, and topicals; and potent products, as well as performs contract development and manufacturing of pharmaceutical products for other companies. It markets its products through retail pharmacy chains, wholesalers, distributors and mail order pharmacies, and group purchasing organizations. The company was incorporated in 2001 and is headquartered in Baudette, Minnesota.
How the Company Makes MoneyANI Pharmaceuticals generates revenue through the sale of its prescription drugs, which include both branded and generic medications. The company's revenue model is primarily based on the direct sales of its pharmaceutical products to wholesalers, pharmacies, and healthcare providers. Key revenue streams include sales from its proprietary branded products and the generic drugs it manufactures. Additionally, ANI Pharmaceuticals benefits from partnerships and collaborations with other pharmaceutical companies, which can include co-development agreements, licensing deals, and supply agreements. These partnerships can provide additional revenue through milestone payments, royalties, and shared profits from jointly developed products. The company also focuses on expanding its product offerings and entering new markets to increase its overall revenue potential.

ANI Pharmaceuticals Earnings Call Summary

Earnings Call Date:Nov 10, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Feb 26, 2026
Earnings Call Sentiment Positive
The earnings call presented a strong performance by ANI Pharmaceuticals, with record-breaking revenue and significant growth driven by the Rare Disease and Generics segments. Despite challenges in the ILUVIEN segment and Medicare funding affecting Retina products, the company raised its financial guidance and demonstrated robust cash flow and debt management.
Q3-2025 Updates
Positive Updates
Record Revenue and Growth
ANI Pharmaceuticals achieved record revenue, adjusted EBITDA, and adjusted EPS in Q3 2025. Total company revenues increased by 54% year-over-year and 46% on an organic basis.
Cortrophin Gel Revenue Surge
Cortrophin Gel net revenue nearly doubled compared to Q3 2024, contributing to a 70% year-over-year growth in adjusted EBITDA. Cortrophin Gel is expected to grow 75% to 78% year-over-year to generate revenues of $347 million to $352 million.
Generics Business Performance
The Generics business had a strong performance due to an opportunistic partner generic launch, leading to expected Generics growth for the full year in the low 20% range.
Increased Financial Guidance
ANI Pharmaceuticals raised its full-year 2025 financial guidance, expecting net revenues to grow 39% to 42% and adjusted EBITDA between 42% and 46% compared to 2024.
Cash Flow and Debt Management
ANI Pharmaceuticals ended Q3 with $262.6 million in unrestricted cash, up from $217.8 million in Q2, and reduced net leverage to 1.7x trailing 12-month adjusted EBITDA.
Negative Updates
ILUVIEN Sales Decline
ILUVIEN sales were lower due to reduced access for Medicare patients and the utilization of remaining YUTIQ units. 2025 is seen as a reset year for ILUVIEN with expected growth in 2026.
Challenges with Medicare Funding
Co-pay foundations did not receive sufficient funding, affecting Medicare patients' access to Retina products, impacting ILUVIEN sales.
Generics Margin Pressure
The gross margin for a partner generic product was lower than typical due to a profit share element, impacting overall margins.
Company Guidance
In the ANI Pharmaceuticals Q3 2025 earnings call, the company reported robust growth, with total revenues increasing by 54% year-over-year and 46% on an organic basis. Cortrophin Gel net revenue nearly doubled compared to Q3 2024, and adjusted EBITDA grew by 70% year-over-year. Based on this strong performance, ANI Pharmaceuticals raised its 2025 financial guidance, projecting a 39% to 42% increase in net revenues and a 34% to 37% organic growth compared to 2024. The company expects Cortrophin Gel to grow by 75% to 78% year-over-year, generating revenues of $347 million to $352 million. Adjusted EBITDA is anticipated to grow between 42% and 46% compared to 2024. The Rare Disease business, particularly Cortrophin Gel, is highlighted as a primary growth driver, with clinical evidence generation and commercial efforts supporting its expansion. Additionally, ANI Pharmaceuticals noted a strong third quarter in its Generics business, driven by an opportunistic partner generic launch, with expected full-year growth in the low 20% range.

ANI Pharmaceuticals Financial Statement Overview

Summary
ANI Pharmaceuticals shows strong revenue growth and cash flow generation, but faces challenges in profitability and return on equity. The balance sheet indicates improved leverage management, yet operational efficiency needs enhancement.
Income Statement
65
Positive
ANI Pharmaceuticals has shown a positive revenue growth rate of 10.63% in the TTM, indicating strong sales momentum. However, the net profit margin remains negative, suggesting challenges in achieving profitability. The gross profit margin is healthy at 57.95%, but the EBIT and EBITDA margins are relatively low, indicating potential inefficiencies in operations.
Balance Sheet
60
Neutral
The company has improved its debt-to-equity ratio to 0.73 in the TTM, reflecting better leverage management compared to previous periods. However, the return on equity remains negative, indicating that the company is not generating sufficient returns on shareholders' equity. The equity ratio is stable, suggesting a balanced asset structure.
Cash Flow
70
Positive
ANI Pharmaceuticals has demonstrated strong free cash flow growth of 28.75% in the TTM, highlighting improved cash generation capabilities. The operating cash flow to net income ratio is robust, indicating efficient cash conversion. However, the free cash flow to net income ratio suggests that a significant portion of cash flow is not translating into net income.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue826.88M614.38M486.82M316.38M216.14M208.47M
Gross Profit482.93M364.17M305.30M177.60M115.53M121.32M
EBITDA163.62M63.12M106.60M25.04M3.12M28.13M
Net Income38.09M-18.52M18.78M-47.90M-42.60M-22.55M
Balance Sheet
Total Assets1.41B1.28B904.42M760.09M771.60M461.19M
Cash, Cash Equivalents and Short-Term Investments262.61M151.17M221.12M48.23M100.30M7.86M
Total Debt322.63M624.09M285.67M286.52M287.37M185.69M
Total Liabilities902.34M855.17M446.82M421.55M412.86M265.49M
Stockholders Equity505.82M428.53M457.60M338.54M358.74M195.70M
Cash Flow
Free Cash Flow135.32M47.06M100.45M-47.66M-20.32M-53.05M
Operating Cash Flow170.72M64.02M118.96M-31.20M3.32M15.27M
Investing Cash Flow-43.60M-404.72M-18.51M-15.74M-105.48M-68.32M
Financing Cash Flow-10.21M264.94M67.44M-5.13M194.59M-1.44M

ANI Pharmaceuticals Technical Analysis

Technical Analysis Sentiment
Positive
Last Price85.03
Price Trends
50DMA
83.02
Positive
100DMA
88.26
Negative
200DMA
77.93
Positive
Market Momentum
MACD
-0.29
Negative
RSI
57.20
Neutral
STOCH
73.81
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ANIP, the sentiment is Positive. The current price of 85.03 is above the 20-day moving average (MA) of 80.90, above the 50-day MA of 83.02, and above the 200-day MA of 77.93, indicating a bullish trend. The MACD of -0.29 indicates Negative momentum. The RSI at 57.20 is Neutral, neither overbought nor oversold. The STOCH value of 73.81 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for ANIP.

ANI Pharmaceuticals Risk Analysis

ANI Pharmaceuticals disclosed 75 risk factors in its most recent earnings report. ANI 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

ANI 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
79
Outperform
$1.28B12.3114.84%-0.03%-27.66%
69
Neutral
$956.79M49.852.90%3.14%
66
Neutral
$1.91B52.157.83%48.87%
57
Neutral
$2.10B-3,909.09-0.32%79.88%99.60%
57
Neutral
$1.78B-316.43-9.54%47.83%84.72%
55
Neutral
$2.97B-152.00-1.86%4.54%-130.59%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ANIP
ANI Pharmaceuticals
85.03
27.53
47.88%
AVDL
Avadel Pharmaceuticals
21.50
13.50
168.75%
PCRX
Pacira Pharmaceuticals
22.24
0.18
0.82%
SUPN
Supernus Pharmaceuticals
51.80
13.93
36.78%
AMPH
Amphastar Pharmaceuticals
27.76
-7.90
-22.15%
HROW
Harrow Health
48.16
14.70
43.93%

ANI Pharmaceuticals Corporate Events

Business Operations and StrategyFinancial Disclosures
ANI Pharmaceuticals issues strong 2025 preliminary results, 2026 outlook
Positive
Jan 12, 2026

On January 12, 2026, ANI Pharmaceuticals reported strong preliminary, unaudited results for 2025, highlighting that total net revenues, adjusted non-GAAP EBITDA and adjusted non-GAAP diluted EPS are expected to meet or exceed prior guidance, with Cortrophin Gel net revenues rising 76% year over year to about $347.8 million and ILUVIEN and YUTIQ contributing $74.9 million. The company, which ended 2025 with roughly $285 million in unrestricted cash, projected further acceleration in 2026 with total net revenues guided to $1.055 billion–$1.115 billion, adjusted non-GAAP EBITDA of $275 million–$290 million, and rare disease products expected to account for about 60% of sales, underpinned by a 55%–65% revenue surge in Cortrophin Gel. To support this growth and reinforce its transition into a leading rare disease player, ANI plans a roughly 90-person expansion of its rare disease organization by mid-2026 to capitalize on the acute gouty arthritis flare opportunity, continue investment in a Phase 4 trial for Cortrophin Gel, return ILUVIEN to growth, maintain 10–15 new generic launches annually, and pursue disciplined capital allocation aimed at scaling its rare disease business while sustaining cash generation from generics.

The most recent analyst rating on (ANIP) stock is a Buy with a $100.00 price target. To see the full list of analyst forecasts on ANI Pharmaceuticals stock, see the ANIP Stock Forecast page.

Executive/Board ChangesShareholder Meetings
ANI Pharmaceuticals Announces Leadership Transition in Board
Neutral
Dec 1, 2025

On November 24, 2025, Patrick D. Walsh announced he would not seek re-election as a director at ANI Pharmaceuticals‘ 2026 Annual Meeting and stepped down as Chairman of the Board. Thomas J. Haughey was elected as the new Chairman, while Jeanne A. Thoma replaced him as Chair of the Audit and Finance Committee. This leadership transition is expected to support ANI’s focus on expanding its Rare Disease business and delivering growth for shareholders.

The most recent analyst rating on (ANIP) stock is a Hold with a $93.00 price target. To see the full list of analyst forecasts on ANI Pharmaceuticals stock, see the ANIP Stock Forecast page.

Business Operations and StrategyFinancial Disclosures
ANI Pharmaceuticals Highlights November 2025 Financial Strategies
Neutral
Nov 10, 2025

ANI Pharmaceuticals released a corporate presentation in November 2025, highlighting its financial performance and strategic initiatives. The company emphasized its focus on achieving profitability through the commercialization of its approved products and managing the impacts of recent acquisitions, such as Alimera. ANI also discussed various risks and uncertainties affecting its operations, including supply chain disruptions and regulatory challenges, while providing insights into its financial measures like adjusted non-GAAP EBITDA and earnings per share.

The most recent analyst rating on (ANIP) stock is a Buy with a $121.00 price target. To see the full list of analyst forecasts on ANI Pharmaceuticals stock, see the ANIP 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: Jan 13, 2026