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ANI Pharmaceuticals Inc (ANIP)
NASDAQ:ANIP

ANI Pharmaceuticals (ANIP) AI Stock Analysis

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ANI Pharmaceuticals

(NASDAQ:ANIP)

65Neutral
ANI Pharmaceuticals exhibits strong revenue growth potential and positive market momentum, but faces significant profitability and valuation challenges. The positive guidance for 2025 and operational efficiencies offer a cautiously optimistic outlook, but high leverage and net losses remain key risks. Investors should weigh growth potential against financial and operational challenges.
Positive Factors
Financial Performance
ANI Pharmaceuticals reported financial results that exceeded their pre-announcement on both the top and bottom lines.
Growth Prospects
Cortrophin Gel is experiencing significant growth and is expected to benefit further from a pre-filled syringe launch, indicating a positive outlook for the product.
Negative Factors
Operational Challenges
The Iluvien and Yutiq franchise faces transitional challenges, with sales guidance flat year-over-year and below estimates due to manufacturing issues.

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

ANI Pharmaceuticals Business Overview & Revenue Model

Company DescriptionANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company that develops, manufactures, and markets high-quality generic and branded pharmaceuticals. Operating primarily in the specialty pharmaceuticals sector, the company focuses on niche areas such as rare diseases and complex formulations. ANI's product portfolio includes a wide range of prescription pharmaceuticals, with an emphasis on controlled substances, anti-cancer (oncolytics), hormones, and steroids.
How the Company Makes MoneyANI Pharmaceuticals generates revenue through the development, manufacturing, and sale of both generic and branded pharmaceutical products. The company's revenue model primarily involves manufacturing pharmaceuticals for direct sale to wholesalers, retail chains, and other pharmaceutical distributors. Key revenue streams include sales of generic drugs, which offer more affordable alternatives to brand-name medications, and branded pharmaceuticals that address needs in specialized markets. Additionally, ANI engages in strategic partnerships and collaborations with other pharmaceutical companies to enhance its product offerings and market reach. These partnerships can involve co-development, licensing arrangements, or distribution agreements that contribute to its earnings. The company's ability to consistently innovate and expand its product portfolio in response to market demands is a significant factor in its financial performance.

ANI Pharmaceuticals Financial Statement Overview

Summary
ANI Pharmaceuticals shows strong revenue growth and operational cash flow, but persistent net losses are impacting profitability and net profit margins. The high leverage indicated by the Debt-to-Equity Ratio poses a risk, although the equity ratio is stable.
Income Statement
65
Positive
ANI Pharmaceuticals demonstrated considerable revenue growth from $486.82M in 2023 to $614.38M in 2024, a growth rate of 26.2%. However, despite the top line increase, the company reported a net loss of $18.52M in 2024, resulting in a negative net profit margin. The gross profit margin is strong, indicating effective management of production costs. The EBIT and EBITDA margins have decreased considerably compared to prior years, reflecting operational challenges affecting profitability.
Balance Sheet
60
Neutral
The company maintains a relatively high Debt-to-Equity Ratio of 0.78, indicating significant leverage which could pose a risk in volatile markets. However, a solid equity ratio of 31.4% suggests a stable capital structure. The decline in stockholders' equity from previous years highlights potential financial strain. Return on Equity is negative due to net losses, impacting investor returns.
Cash Flow
70
Positive
Operating cash flow remains robust at $64.02M in 2024, providing some cushion against net losses. The free cash flow to net income ratio is distorted by the net loss but indicates a focus on maintaining liquidity. Despite negative free cash flow growth due to increased capital expenditures, the company maintains a good operating cash flow to net income ratio, suggesting operational efficiency.
Breakdown
Dec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
614.38M486.82M316.38M216.14M208.47M
Gross Profit
614.38M305.30M177.60M115.53M121.32M
EBIT
584.00K46.97M-25.06M-32.51M-16.06M
EBITDA
63.12M106.60M48.07M-1.68M29.07M
Net Income Common Stockholders
-18.52M18.78M-47.90M-42.60M-22.55M
Balance SheetCash, Cash Equivalents and Short-Term Investments
151.17M221.12M48.23M100.30M7.86M
Total Assets
1.28B904.42M760.09M771.60M461.19M
Total Debt
314.98M285.67M286.52M287.37M185.69M
Net Debt
170.12M64.55M238.29M187.07M177.82M
Total Liabilities
855.17M446.82M421.55M412.86M265.49M
Stockholders Equity
428.53M457.60M338.54M358.74M195.70M
Cash FlowFree Cash Flow
64.02M100.45M-47.66M-20.32M-53.05M
Operating Cash Flow
64.02M118.96M-31.20M3.32M15.27M
Investing Cash Flow
-404.72M-18.51M-15.74M-105.48M-68.32M
Financing Cash Flow
264.94M67.44M-5.13M194.59M-1.44M

ANI Pharmaceuticals Technical Analysis

Technical Analysis Sentiment
Positive
Last Price61.40
Price Trends
50DMA
57.83
Positive
100DMA
57.75
Positive
200DMA
59.50
Positive
Market Momentum
MACD
0.57
Negative
RSI
57.35
Neutral
STOCH
71.03
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 61.4 is above the 20-day moving average (MA) of 58.73, above the 50-day MA of 57.83, and above the 200-day MA of 59.50, indicating a bullish trend. The MACD of 0.57 indicates Negative momentum. The RSI at 57.35 is Neutral, neither overbought nor oversold. The STOCH value of 71.03 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 67 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 (49)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
68
Neutral
$3.74B-3.53%4.02%-6.05%-1677.05%
65
Neutral
$1.34B-4.86%26.20%-219.22%
62
Neutral
$2.70B106.97%16.73%-22.44%
49
Neutral
$6.90B-0.08-53.01%2.43%24.84%-3.06%
48
Neutral
$16.58M-19.50%14014.81%75.61%
43
Neutral
$1.56M-110.87%85.66%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ANIP
ANI Pharmaceuticals
61.40
-4.83
-7.29%
PRGO
Perrigo Company
27.88
-1.94
-6.51%
LPCN
Lipocine
3.10
-1.69
-35.28%
SLRX
Salarius Pharmaceuticals
0.94
-4.02
-81.05%
AMRX
Amneal Pharmaceuticals
8.84
3.44
63.70%

ANI Pharmaceuticals Earnings Call Summary

Earnings Call Date: Feb 28, 2025 | % Change Since: 12.50% | Next Earnings Date: May 7, 2025
Earnings Call Sentiment Positive
ANI Pharmaceuticals demonstrated strong performance in 2024, with record results and increased guidance for 2025. The company showed significant growth in its Rare Disease and Generics businesses and completed a strategic acquisition. However, there are challenges related to market access for ILUVIEN and YUTIQ and potential disruptions due to manufacturing transitions. Despite these challenges, the positive momentum and strategic initiatives in place suggest a cautiously optimistic outlook.
Highlights
Record Fourth Quarter and Full Year Results
ANI Pharmaceuticals reported record fourth quarter and full year 2024 results, with total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS all coming in above previously announced guidance.
Increased 2025 Revenue and EBITDA Guidance
The company raised its 2025 guidance for total revenues to $756 million to $776 million, representing growth of 23% to 26%, and adjusted non-GAAP EBITDA to $190 million to $200 million, reflecting growth of 22% to 28% over 2024.
Strong Growth in Cortrophin Gel
Cortrophin Gel generated $59.4 million in revenues during Q4 2024, up 42% over Q4 2023. The product continues on a strong multiyear growth trajectory with expected revenues to grow between 34% and 38% in 2025.
Generics Business Growth
The Generics business delivered 12% revenue growth in 2024, driven by operational excellence and new product launches. The business is expected to achieve low double-digit growth in 2025.
Successful Acquisition of Alimera Sciences
ANI expanded its rare disease franchise with the acquisition of Alimera Sciences, adding ophthalmology products ILUVIEN and YUTIQ, which generated $27.6 million in Q4.
Lowlights
Challenges in ILUVIEN and YUTIQ Market Access
Since early January 2025, changes in U.S. market access dynamics reduced access for Medicare patients, impacting ILUVIEN and YUTIQ, particularly significant for ILUVIEN's DME indication.
Potential Disruption from Manufacturing Transition
ANI is transitioning manufacturing of YUTIQ to Siegfried in 2025, which may present challenges, although EyePoint is committed to assisting with supply continuity.
Seasonal Decline in Rare Disease Revenue
Typical Q4 to Q1 impact driven by insurance resets and purchasing patterns is expected to cause Q1 2025 revenue for ILUVIEN and YUTIQ to be lower than Q4 2024.
Company Guidance
During ANI Pharmaceuticals' fourth quarter 2024 earnings call, the company announced an increase in their 2025 guidance for total revenues and adjusted non-GAAP EBITDA, citing strong performance and growth initiatives. For 2025, ANI expects revenue to range between $756 million and $776 million, marking a 23% to 26% growth over 2024, compared to their prior forecast of $739 million to $759 million. The adjusted non-GAAP EBITDA is projected to be between $190 million and $200 million, reflecting a 22% to 28% increase over the prior year’s expectations of $182 million to $192 million. Key growth drivers include higher demand for Cortrophin Gel, anticipated revenue from new ophthalmology products ILUVIEN and YUTIQ, and generics, including the launch of Prucalopride. Cortrophin Gel alone is forecasted to generate between $265 million and $274 million, representing a 34% to 38% increase, while ILUVIEN and YUTIQ are expected to contribute $97 million to $103 million in sales. The company also emphasized strategic growth through acquisitions and operational efficiencies, including the expansion of their ophthalmology sales team and clinical trial investments.

ANI Pharmaceuticals Corporate Events

M&A TransactionsBusiness Operations and StrategyFinancial Disclosures
ANI Pharmaceuticals Discusses Alimera Acquisition Challenges
Negative
Mar 11, 2025

ANI Pharmaceuticals recently participated in the Leerink Partners Global Healthcare Conference on March 11, 2025, where it discussed its financial performance and strategic initiatives. The company highlighted the challenges and risks associated with its recent acquisition of Alimera, including potential disruptions to its business and financial position. ANI Pharmaceuticals also emphasized the importance of its adjusted non-GAAP financial measures, such as EBITDA and diluted earnings per share, as indicators of its operating performance, while acknowledging the uncertainties and risks that could impact its future results.

Business Operations and StrategyFinancial Disclosures
ANI Pharmaceuticals Shares Strategic Insights at Conference
Neutral
Feb 5, 2025

The recent presentation by ANI Pharmaceuticals at the Guggenheim SMID Cap Biotech Conference on February 5, 2025, provided insights into its forward-looking strategies, including the commercial success and market expansion of its rare disease product, Cortrophin Gel. The company discussed its financial performance metrics, such as adjusted non-GAAP EBITDA and diluted earnings per share, which are utilized to gauge operating performance while considering various potential risks and uncertainties affecting the pharmaceutical industry, including regulatory changes, supply chain disruptions, and geopolitical factors.

M&A TransactionsBusiness Operations and StrategyFinancial Disclosures
ANI Pharmaceuticals Projects Strong Growth for 2025
Positive
Jan 13, 2025

ANI Pharmaceuticals announced its preliminary financial results for 2024 and outlook for 2025, affirming its net revenues and earnings guidance for 2024 and projecting significant growth in 2025. The company reported strong performance in its Rare Disease segment following the acquisition of Alimera, with expectations of continued robust growth driven by this franchise. The preliminary 2025 financial targets reflect a projected revenue growth of 24% to 27%, indicating a positive outlook for stakeholders.

Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.