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ANI Pharmaceuticals Inc (ANIP)
NASDAQ:ANIP

ANI Pharmaceuticals (ANIP) AI Stock Analysis

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ANI Pharmaceuticals

(NASDAQ:ANIP)

Rating:64Neutral
Price Target:
$66.00
▲(6.25%Upside)
ANI Pharmaceuticals' overall stock score reflects strong revenue growth and cash flow generation, which are offset by challenges in profitability and technical indicators. Increased future guidance and strategic corporate decisions provide a positive outlook, but risks from market access issues and acquisitions remain significant.
Positive Factors
Financial Performance
ANIP reported earnings highlighted by a consensus beat on revenue and adj. EBITDA and an incremental raise to 2025 guidance.
Product Launch
The beat was driven primarily by the generics segment, which benefited from a new product launch.
Regulatory Approval
The FDA approved an expanded Iluvien label, adding chronic non-infection uveitis affecting the posterior segment (NIU-PS) to the current DME indication, which came earlier than expected and reflects continued ANI regulatory execution.
Negative Factors
Legal Dispute
ANIP is currently in a legal dispute regarding the rights to receive a 5% royalty from CGON's cretostimogene sales.
Rare Disease Segment
Rare disease segment is experiencing a sequential step-down due to seasonality, which seems appropriately reflected in consensus estimates.
Risk of Generic Launch
Risks include the possibility of generic launches falling short, limited track record for Iluvien/Yutiq, and potential failure to drive Cortrophin volumes.

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

ANI Pharmaceuticals Business Overview & Revenue Model

Company DescriptionANI Pharmaceuticals, Inc. (ANIP) is a specialty pharmaceutical company engaged in developing, manufacturing, and marketing high-quality generic and branded prescription pharmaceuticals. ANI's portfolio includes complex formulations, controlled substances, and niche generic products, serving various therapeutic areas such as oncology, hormones, and controlled substances. The company emphasizes innovation and quality to fulfill unmet medical needs while maintaining a strong commitment to regulatory compliance and quality assurance.
How the Company Makes MoneyANI Pharmaceuticals generates revenue primarily through the sale of its generic and branded pharmaceutical products. The company focuses on launching new products and expanding its portfolio to enhance its market presence. ANI leverages its manufacturing facilities to produce complex formulations and controlled substances, which often have higher barriers to entry, allowing for premium pricing and reduced competition. The company also forms strategic partnerships and collaborations to expand its reach and capabilities. Significant factors contributing to ANI's earnings include its ability to bring new products to market efficiently, manage its supply chain effectively, and maintain strong relationships with key stakeholders such as healthcare providers, distributors, and regulatory bodies.

ANI Pharmaceuticals Earnings Call Summary

Earnings Call Date:May 09, 2025
(Q1-2025)
|
% Change Since: -13.16%|
Next Earnings Date:Aug 06, 2025
Earnings Call Sentiment Positive
ANI Pharmaceuticals demonstrated strong growth with record revenue and increased guidance, driven by the generics and Cortrophin Gel segments. However, challenges remain with market access and salesforce turnover affecting the retina products. The company is addressing these issues through strategic investments and operational adjustments.
Q1-2025 Updates
Positive Updates
Record Revenue and Growth
ANI Pharmaceuticals reported record revenue of $197.1 million for Q1 2025, a 43% year-over-year increase on an as-reported basis and 32% on an organic basis. This performance was driven by exceptional growth in generics, Cortrophin Gel, and the brands portfolio.
Increased 2025 Guidance
Based on the strong performance in Q1, ANI Pharmaceuticals raised its 2025 revenue guidance to $768 million to $793 million, representing growth of 25% to 29% over 2024.
Cortrophin Gel Growth
Cortrophin Gel generated $52.9 million in Q1 revenue, up 43% from the first quarter of 2024. The company expects Cortrophin Gel revenues to increase 34% to 38% for the year.
Generics Business Performance
The generics segment delivered strong Q1 revenue of $98.7 million, an increase of 41% over Q1 2024, driven by new product launches and strong base business execution.
Strategic Investments and New Approvals
ANI made strategic moves including the buyout of the royalty obligation on ILUVIEN and YUTIQ, and launched a pre-filled syringe for Cortrophin Gel, which received positive feedback.
Negative Updates
Challenges with Retina Products
Revenues from ILUVIEN and YUTIQ were $16.1 million in Q1, impacted by market access challenges for Medicare patients and turnover in the US ophthalmology sales force.
Medicare Access Issues
The first quarter was affected by reduced access for Medicare patients due to insufficient funding for patient support foundations, impacting products reimbursed under Medicare Part B.
Salesforce Turnover
There was turnover in the US Ophthalmology Salesforce, affecting performance. The company is in the process of strengthening the team with new hires.
Company Guidance
During ANI Pharmaceuticals' Q1 2025 earnings call, the company reported a robust financial performance, achieving record revenue, adjusted EBITDA, and adjusted EPS. Based on the first quarter's success and favorable demand trends, ANI raised its 2025 guidance for total revenues to $768 million to $793 million, reflecting a 25% to 29% growth over 2024. Adjusted non-GAAP EBITDA is now expected to range from $195 million to $205 million, up 25% to 31% from the previous year. The company's revenue for the first quarter was $197.1 million, marking a 43% year-over-year increase. Key drivers included strong performance in the generics segment, which grew by 41% to $98.7 million, and the rare disease segment, particularly Cortrophin Gel, which saw a 43% increase in revenue to $52.9 million. The guidance also maintained expectations for Cortrophin Gel revenues to reach $265 million to $274 million, with ILUVIEN and YUTIQ revenues predicted to be between $97 million and $103 million, despite some market access challenges in the U.S. Additionally, ANI's generics business is projected to experience mid-double-digit growth throughout the year.

ANI Pharmaceuticals Financial Statement Overview

Summary
ANI Pharmaceuticals exhibits strong revenue growth and cash flow generation. However, it faces challenges with net profitability and ROE due to ongoing expenses and financial costs. The balance sheet shows moderate leverage but needs improvement in equity returns.
Income Statement
65
Positive
ANI Pharmaceuticals has shown a consistent increase in revenue over the years, with a notable TTM growth rate of approximately 9.71% from the previous year. The gross profit margin for the TTM is 57.14%, indicating strong product profitability. However, the net profit margin remains negative at -3.12% for the TTM, highlighting ongoing challenges in controlling expenses or non-operational costs. The EBIT and EBITDA margins are positive but modest, suggesting room for operational efficiency improvements.
Balance Sheet
58
Neutral
The company's balance sheet shows a moderate debt-to-equity ratio of 0.76, reflecting a balanced approach to leverage. However, the return on equity is negative at -5.03% for the TTM due to net losses, indicating inefficiencies in generating returns for shareholders. The equity ratio is 32.39%, suggesting a reasonable level of equity financing, but there is room for strengthening the equity base to improve financial stability.
Cash Flow
72
Positive
ANI Pharmaceuticals' cash flow statement reveals a strong free cash flow growth of 45.28% in the TTM, demonstrating effective cash generation capabilities. The operating cash flow to net income ratio is favorable at 3.84, indicating good cash earnings conversion. The free cash flow to net income ratio is also positive at 3.25, highlighting efficient cash management despite net losses.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
674.07M614.38M486.82M316.38M216.14M208.47M
Gross Profit
385.28M364.17M305.30M177.60M115.53M121.32M
EBIT
6.83M584.00K46.97M-25.06M-32.51M-16.06M
EBITDA
76.14M79.15M106.60M48.07M-1.68M29.07M
Net Income Common Stockholders
-21.05M-18.52M18.78M-47.90M-42.60M-22.55M
Balance SheetCash, Cash Equivalents and Short-Term Investments
149.80M151.17M221.12M48.23M100.30M7.86M
Total Assets
1.29B1.28B904.42M760.09M771.60M461.19M
Total Debt
317.53M624.09M285.67M286.52M287.37M185.69M
Net Debt
167.73M479.23M64.55M238.29M187.07M177.82M
Total Liabilities
848.96M855.17M446.82M421.55M412.86M265.49M
Stockholders Equity
418.62M428.53M457.60M338.54M358.74M195.70M
Cash FlowFree Cash Flow
68.37M47.06M100.45M-47.66M-20.32M-53.05M
Operating Cash Flow
80.74M64.02M118.96M-31.20M3.32M15.27M
Investing Cash Flow
-433.50M-404.72M-18.51M-15.74M-105.48M-68.32M
Financing Cash Flow
274.76M264.94M67.44M-5.13M194.59M-1.44M

ANI Pharmaceuticals Technical Analysis

Technical Analysis Sentiment
Positive
Last Price62.12
Price Trends
50DMA
65.17
Negative
100DMA
62.91
Negative
200DMA
60.37
Positive
Market Momentum
MACD
-0.71
Negative
RSI
51.80
Neutral
STOCH
84.49
Negative
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 62.12 is above the 20-day moving average (MA) of 60.15, below the 50-day MA of 65.17, and above the 200-day MA of 60.37, indicating a neutral trend. The MACD of -0.71 indicates Negative momentum. The RSI at 51.80 is Neutral, neither overbought nor oversold. The STOCH value of 84.49 is Negative, 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 (54)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
79
Outperform
$1.27B9.4519.90%8.05%-8.46%
76
Outperform
$976.16M24.4719.23%17.17%-51.97%
73
Outperform
$1.86B30.026.32%11.82%
64
Neutral
$1.36B-5.19%30.26%-173.36%
59
Neutral
$1.15B-12.27%3.08%-247.82%
54
Neutral
$5.38B3.31-45.11%3.29%16.82%0.04%
48
Neutral
$1.25B64.45-10.45%24.76%-783.38%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ANIP
ANI Pharmaceuticals
62.12
-0.50
-0.80%
DVAX
Dynavax
10.40
-1.15
-9.96%
PCRX
Pacira Pharmaceuticals
24.45
-3.68
-13.08%
SUPN
Supernus Pharmaceuticals
32.77
6.78
26.09%
AMPH
Amphastar Pharmaceuticals
26.44
-14.05
-34.70%
COLL
Collegium Pharmaceutical
29.60
-2.16
-6.80%

ANI Pharmaceuticals Corporate Events

Business Operations and StrategyFinancial DisclosuresRegulatory Filings and Compliance
ANI Pharmaceuticals Highlights Financial Performance Amid Challenges
Neutral
Jun 4, 2025

ANI Pharmaceuticals has highlighted its financial performance indicators, emphasizing the importance of adjusted non-GAAP EBITDA and diluted earnings per share as measures of its operating performance. The company is addressing the impact of recent acquisitions, supply chain disruptions, and regulatory challenges on its operations, while also focusing on maintaining profitability and market acceptance of its products.

The most recent analyst rating on (ANIP) stock is a Buy with a $94.00 price target. To see the full list of analyst forecasts on ANI Pharmaceuticals stock, see the ANIP Stock Forecast page.

Shareholder MeetingsBusiness Operations and Strategy
ANI Pharmaceuticals Approves Key Proposals at Annual Meeting
Positive
May 23, 2025

ANI Pharmaceuticals, Inc. held its 2025 Annual Meeting of Stockholders on May 22, 2025, where several key proposals were approved. These included amendments to the company’s stock plans and an increase in authorized shares of common stock, reflecting strategic moves to bolster its financial and operational flexibility. The meeting also saw the election of eight directors and the ratification of the appointment of EisnerAmper LLP as the independent registered public accounting firm, indicating a stable governance and financial oversight structure for the upcoming fiscal year.

The most recent analyst rating on (ANIP) stock is a Buy with a $94.00 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 Releases May 2025 Financial Presentation
Neutral
May 20, 2025

ANI Pharmaceuticals has released a corporate presentation detailing its financial performance and strategic initiatives as of May 2025. The company emphasizes the importance of adjusted non-GAAP financial measures, such as EBITDA and diluted earnings per share, as key indicators of its operating performance. These metrics exclude various non-cash and one-time expenses to provide a clearer picture of the company’s financial health. The presentation also highlights potential risks and uncertainties, including supply chain disruptions and regulatory challenges, which could impact its operations and financial results.

The most recent analyst rating on (ANIP) stock is a Buy with a $94.00 price target. To see the full list of analyst forecasts on ANI Pharmaceuticals stock, see the ANIP Stock Forecast page.

Shareholder MeetingsRegulatory Filings and Compliance
ANI Pharmaceuticals Files Proxy for 2025 Meeting
Neutral
May 8, 2025

On April 10, 2025, ANI Pharmaceuticals filed a definitive proxy statement for its 2025 annual meeting of shareholders to consider several proposals, including the approval of the Amended and Restated 2022 Stock Incentive Plan. The company issued a Proxy Supplement to clarify that non-shareholder approved inducement grants are included in the share reserve increase proposal. As of March 24, 2025, ANI Pharmaceuticals had 1,177,800 shares available for future grants under the Stock Plan, which is deemed insufficient to attract and retain key talent. The company emphasizes the importance of the Stock Plan in its compensation strategy, aligning with market standards to motivate and retain employees.

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.