ANI Pharmaceuticals (ANIP) AI Stock Analysis

• Market Cap: $2.06B
• Dividend Yield: N/A
• Average Volume (3M): 476.61K
• Price to Earnings (P/E): ―
• Beta (1Y): 0.50
• Revenue Growth: 38.68%
• EPS Growth: -160.14%
• Country: US
• Employees: 897
• Sector: Healthcare
• Sector Strength: 45
• Industry: Drug Manufacturers - Specialty & Generic
• EPS (TTM): 1.80
• Shares Outstanding: 21,688,772
• 10 Day Avg. Volume: 346,177
• 30 Day Avg. Volume: 476,614
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• P/FCF Ratio: N/A
• Enterprise Value/Market Cap: 0.85
• Enterprise Value/Revenue: 2.34
• Enterprise Value/Gross Profit: 4.04
• Enterprise Value/Ebitda: 18.51
• 1Y Price Target: $102.57
• Price Target Upside: 9.85% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 7

• Rating: 66 Neutral
• Price Target: $97.00 ▲(3.89% Upside)

ANI Pharmaceuticals' overall stock score is driven by strong earnings call results and technical momentum, despite valuation concerns and profitability challenges. The company's raised guidance and product performance are significant positives, while the negative P/E ratio and overbought technical indicators pose risks.

Positive Factors

Revenue Growth

Record revenue growth indicates strong market demand and effective product strategy, enhancing long-term business sustainability.

Product Performance

Strong performance of Cortrophin Gel highlights successful product execution and potential for sustained revenue contributions.

Cash Flow Generation

Robust cash flow generation supports operational needs and strategic investments, ensuring financial stability and growth.

Negative Factors

Profitability Challenges

Ongoing profitability issues could hinder reinvestment and shareholder returns, affecting long-term financial health.

Market Access Challenges

Access issues in the retina segment may limit revenue potential and market expansion, impacting future growth.

Legal Dispute

Legal disputes can lead to financial liabilities and distract management, potentially affecting strategic focus and resources.

ANI Pharmaceuticals Business Overview & Revenue Model

Company Description

ANI 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 Money

ANI Pharmaceuticals generates revenue primarily through the sale of its branded and generic pharmaceutical products. The company has a diversified revenue model that includes direct sales to wholesalers, distributors, and retail pharmacies. Key revenue streams arise from the commercialization of its product portfolio, which consists of both established medications and newly developed products. Additionally, ANI Pharmaceuticals may engage in partnerships and collaborations with other pharmaceutical companies to co-develop or market products, further contributing to its earnings. The company also benefits from cost efficiencies in its manufacturing processes and regulatory approvals that enable it to bring products to market effectively.

ANI Pharmaceuticals Financial Statement Overview

Summary

ANI Pharmaceuticals demonstrates robust revenue growth and effective cash flow management, which are positive indicators of operational strength. However, persistent net losses and negative return on equity highlight ongoing profitability challenges. The company maintains a stable balance sheet with manageable leverage, but improving profitability metrics will be crucial for enhancing overall financial health.

Income Statement

ANI Pharmaceuticals has shown a strong revenue growth trajectory, with a significant increase from $208 million in 2020 to $674 million in TTM (Trailing-Twelve-Months) 2025. The gross profit margin remains healthy, indicating efficient cost management. However, the company has struggled with profitability, as evidenced by negative net income in recent periods, impacting the net profit margin adversely.

Balance Sheet

The balance sheet reflects a moderate debt-to-equity ratio, indicating a balanced approach to leverage. The equity ratio suggests a reasonable level of equity financing, but the return on equity is negative due to net losses, highlighting challenges in generating shareholder returns. Overall, the balance sheet is stable but shows room for improvement in profitability.

Cash Flow

Cash flow analysis reveals a positive trend in operating cash flow, with a notable increase in free cash flow over the years. The operating cash flow to net income ratio is strong, indicating effective cash generation relative to accounting profits. However, the company has faced significant investing cash outflows, which could impact future liquidity if not managed carefully.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	747.40M	614.38M	486.82M	316.38M	216.14M	208.47M
Gross Profit	433.11M	364.17M	305.30M	177.60M	115.53M	121.32M
EBITDA	94.45M	79.15M	106.60M	33.92M	-1.68M	24.23M
Net Income	-11.03M	-18.52M	18.78M	-47.90M	-42.60M	-22.55M
Balance Sheet
Total Assets	1.34B	1.28B	904.42M	760.09M	771.60M	461.19M
Cash, Cash Equivalents and Short-Term Investments	217.80M	151.17M	221.12M	48.23M	100.30M	7.86M
Total Debt	320.08M	624.09M	285.67M	286.52M	287.37M	185.69M
Total Liabilities	906.24M	855.17M	446.82M	421.55M	412.86M	265.49M
Stockholders Equity	436.76M	428.53M	457.60M	338.54M	358.74M	195.70M
Cash Flow
Free Cash Flow	111.37M	47.06M	100.45M	-47.66M	-20.32M	-53.05M
Operating Cash Flow	139.14M	64.02M	118.96M	-31.20M	3.32M	15.27M
Investing Cash Flow	-435.96M	-404.72M	-18.51M	-15.74M	-105.48M	-68.32M
Financing Cash Flow	274.47M	264.94M	67.44M	-5.13M	194.59M	-1.44M

ANI Pharmaceuticals Technical Analysis

• Technical Analysis Sentiment: Neutral
• Last Price: 93.37
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Positive
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ANIP, the sentiment is Neutral. The current price of 93.37 is below the 20-day moving average (MA) of 95.98, above the 50-day MA of 84.52, and above the 200-day MA of 67.55, indicating a neutral trend. The MACD of 2.61 indicates Positive momentum. The RSI at 52.24 is Neutral, neither overbought nor oversold. The STOCH value of 25.67 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for ANIP.

ANI Pharmaceuticals Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
SUPN	71 Outperform	2.64B	41.23	6.06%	―	5.55%	1145.24%
AMPH	69 Neutral	1.25B	9.87	17.78%	―	1.37%	-18.10%
ANIP	66 Neutral	$2.06B	―	-2.82%	―	38.68%	-160.14%
COLL	65 Neutral	1.11B	33.45	15.62%	―	22.61%	-63.00%
PCRX	61 Neutral	1.17B	-9.21	-16.82%	―	2.25%	-301.59%
DVAX	54 Neutral	1.17B	-20.50	-10.67%	―	26.66%	-419.55%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%

ANI Pharmaceuticals Corporate Events

ANI Pharmaceuticals Highlights Commercialization Focus Amid Challenges

ANI Pharmaceuticals‘ recent investor presentation highlights the company’s focus on the commercialization of its approved products and the challenges it faces due to acquisitions and supply chain issues. The presentation also discusses the company’s use of adjusted non-GAAP financial measures to provide a clearer picture of its operating performance, although it does not provide a reconciliation for the full-year 2025 adjusted EBITDA guidance due to insufficient information.

ANI Pharmaceuticals to Challenge Court Verdict

ANI Pharmaceuticals initiated a legal action against CG Oncology in March 2024, alleging a breach of a royalty payment agreement from 2010. The court proceedings in 2025 resulted in a jury verdict that found the royalty provision unenforceable but not materially adverse to ANI Pharmaceuticals, awarding no damages on ANI’s unjust enrichment claim. ANI Pharmaceuticals plans to challenge the verdict through post-trial motions or an appeal.

ANI Pharmaceuticals Reveals NEW DAY Study Results

On July 23, 2025, ANI Pharmaceuticals announced the results of the NEW DAY Study, which focused on the effectiveness of ILUVIEN for treating diabetic macular edema (DME). The study highlighted ILUVIEN’s ability to provide a constant and controlled release of fluocinolone acetonide, offering a potential alternative for patients not well served by anti-VEGF therapies. This announcement may enhance ANI Pharmaceuticals’ positioning in the ophthalmology market by addressing unmet needs in DME treatment and could potentially impact stakeholders by offering a new therapeutic option.

ANI Pharmaceuticals Reports on NEW DAY Clinical Trial Results

ANI Pharmaceuticals, Inc. announced the results of the NEW DAY clinical trial for ILUVIEN®, a treatment for diabetic macular edema (DME). The trial, which was presented at the American Society of Retina Specialists Annual Scientific Meeting, showed that while ILUVIEN reduced the mean number of supplemental aflibercept injections compared to the aflibercept arm, it did not meet the primary endpoint of statistical significance. However, a post-hoc analysis indicated a statistically significant reduction in supplemental injections for a subset of patients. The trial also demonstrated non-inferiority in visual acuity and anatomic changes between the ILUVIEN and aflibercept arms. These findings suggest ILUVIEN’s potential to reduce treatment burden for DME patients, although safety concerns related to increased intraocular pressure were noted.