ANI Pharmaceuticals (ANIP) AI Stock Analysis

• Market Cap: $2.03B
• Dividend Yield: N/A
• Average Volume (3M): 605.59K
• Price to Earnings (P/E): ―
• Beta (1Y): 0.51
• Revenue Growth: 38.68%
• EPS Growth: -160.14%
• Country: US
• Employees: 897
• Sector: Healthcare
• Sector Strength: 51
• Industry: Drug Manufacturers - Specialty & Generic
• EPS (TTM): 1.80
• Shares Outstanding: 21,688,772
• 10 Day Avg. Volume: 475,281
• 30 Day Avg. Volume: 605,586
• 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: 0.86
• Enterprise Value/Revenue: 2.34
• Enterprise Value/Gross Profit: 4.04
• Enterprise Value/Ebitda: 18.51
• 1Y Price Target: $90.14
• Price Target Upside: -4.21% Downside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 7

• Rating: 66 Neutral
• Price Target: $97.00 ▲(3.08% 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

Earnings

ANI Pharmaceuticals reported second quarter revenue of $211.4M and adjusted EBITDA of $54.1M, both above consensus and estimates.

Product Performance

The launch of the pre-filled syringe formulation is off to a solid start supporting raised 2025 guide.

Revenue Growth

ANIP's branded segment continues to scale and is poised to constitute more than 50% of revenues moving forward.

Negative Factors

Legal Outcomes

The trial between ANIP and CGON concluded with the jury siding in favor of CGON, resulting in no royalties or payments due to ANIP.

Market Concerns

Investors wonder if the $97-103M guide for Iluvien is optimistic given 1H25 revenues of $38M and weakness in the ophthalmology buy-and-bill market.

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: Positive
• Last Price: 94.10
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• RSI: Negative
• STOCH: 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 94.1 is above the 20-day moving average (MA) of 85.15, above the 50-day MA of 73.39, and above the 200-day MA of 64.07, indicating a bullish trend. The MACD of 6.25 indicates Negative momentum. The RSI at 81.34 is Negative, neither overbought nor oversold. The STOCH value of 94.19 is Negative, 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	76 Outperform	$2.53B	39.43	6.38%	―	5.55%	1145.24%
COLL	73 Outperform	$1.22B	37.46	16.16%	―	22.61%	-63.00%
AMPH	68 Neutral	$1.42B	11.46	18.32%	―	1.37%	-18.10%
ANIP	66 Neutral	$2.03B	―	-2.82%	―	38.68%	-160.14%
PCRX	61 Neutral	$1.20B	―	-15.57%	―	2.25%	-301.59%
DVAX	54 Neutral	$1.19B	64.45	-9.28%	―	26.66%	-419.55%
Sector *	51 Neutral	$7.86B	-0.33	-41.39%	2.23%	23.26%	-2.03%

ANI Pharmaceuticals Corporate Events

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.

ANI Pharmaceuticals Highlights Financial Performance Amid Challenges

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.

ANI Pharmaceuticals Approves Key Proposals at Annual Meeting

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.

ANI Pharmaceuticals Releases May 2025 Financial Presentation

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.