ANI Pharmaceuticals (ANIP) AI Stock Analysis

• Market Cap: $1.57B
• Dividend Yield: N/A
• Average Volume (3M): 408.18K
• Price to Earnings (P/E): ―
• Beta (1Y): 0.48
• Revenue Growth: 26.20%
• EPS Growth: -219.22%
• Country: US
• Employees: 897
• Sector: Healthcare
• Sector Strength: 60
• Industry: Drug Manufacturers - Specialty & Generic
• EPS (TTM): 1.63
• Shares Outstanding: 21,574,175
• 10 Day Avg. Volume: 377,181
• 30 Day Avg. Volume: 408,178
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): 0.00
• Price to Cash Flow (P/CF): 0.00
• P/FCF Ratio: 0.00
• Enterprise Value/Market Cap: 1.00
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: 2.57
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: $81.50
• Price Target Upside: 12.32% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 7

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

Business Model Transition

ANIP is transitioning from a legacy generics manufacturer to a hybrid business model inclusive of branded rare disease drugs.

Product Development

CGON reported encouraging results for cretostimogene from the Phase 3 BOND-003 study in patients with high-risk non-muscle invasive bladder cancer.

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.

Market Valuation

The stock is trading at a valuation more suitable for a pure generics company, despite significant contributions and growth from the rare disease portfolio.

Product Launch Risk

Risks include the possibility of generic launches falling short, limited track record for Iluvien/Yutiq, and potential failure to drive Cortrophin volumes.

ANI Pharmaceuticals Business Overview & Revenue Model

Company Description

ANI 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 Money

ANI 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 displays strong revenue growth and operational cash flow, but profitability challenges persist with consecutive years of net losses impacting net profit margins. The balance sheet reveals high leverage, which could be risky without improved profitability. Overall, while revenue growth is promising, the company must address its operational and financial challenges to enhance profitability and stability.

Income Statement

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

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

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 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement		Total Revenue
614.38M	486.82M	316.38M	216.14M	208.47M
	Gross Profit
614.38M	305.30M	177.60M	115.53M	121.32M
	EBIT
584.00K	46.97M	-25.06M	-32.51M	-16.06M
	EBITDA
63.12M	106.60M	48.07M	-1.68M	29.07M
	Net Income Common Stockholders
-18.52M	18.78M	-47.90M	-42.60M	-22.55M
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
151.17M	221.12M	48.23M	100.30M	7.86M
	Total Assets
1.28B	904.42M	760.09M	771.60M	461.19M
	Total Debt
314.98M	285.67M	286.52M	287.37M	185.69M
	Net Debt
170.12M	64.55M	238.29M	187.07M	177.82M
	Total Liabilities
855.17M	446.82M	421.55M	412.86M	265.49M
	Stockholders Equity
428.53M	457.60M	338.54M	358.74M	195.70M
Cash Flow		Free Cash Flow
64.02M	100.45M	-47.66M	-20.32M	-53.05M
	Operating Cash Flow
64.02M	118.96M	-31.20M	3.32M	15.27M
	Investing Cash Flow
-404.72M	-18.51M	-15.74M	-105.48M	-68.32M
	Financing Cash Flow
264.94M	67.44M	-5.13M	194.59M	-1.44M

ANI Pharmaceuticals Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 72.56
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• RSI: Neutral
• STOCH: 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 72.56 is above the 20-day moving average (MA) of 68.96, above the 50-day MA of 65.30, and above the 200-day MA of 60.31, indicating a bullish trend. The MACD of 1.78 indicates Negative momentum. The RSI at 66.59 is Neutral, neither overbought nor oversold. The STOCH value of 79.17 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for ANIP.

ANI Pharmaceuticals Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
SUPN	74 Outperform	$1.84B	24.57	7.55%	―	8.94%	5171.26%
AMPH	70 Outperform	$1.16B	8.20	23.26%	―	13.59%	15.72%
COLL	70 Outperform	$888.44M	15.03	32.62%	―	11.41%	45.89%
ANIP	65 Neutral	$1.57B	―	-4.86%	―	26.20%	-219.22%
PCRX	65 Neutral	$1.22B	―	-12.08%	―	3.85%	-339.15%
DVAX	57 Neutral	$1.39B	64.45	4.48%	―	19.36%	―
Sector *	52 Neutral	$5.35B	3.83	-41.61%	2.85%	17.10%	1.22%

ANI Pharmaceuticals Corporate Events

ANI Pharmaceuticals Discusses Alimera Acquisition Challenges

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.