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ANI Pharmaceuticals Inc (ANIP)
NASDAQ:ANIP
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ANI Pharmaceuticals (ANIP) AI Stock Analysis

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ANIP

ANI Pharmaceuticals

(NASDAQ:ANIP)

Rating:75Outperform
Price Target:
$75.00
▲(12.33%Upside)
ANI Pharmaceuticals' overall stock score is driven by strong financial performance and effective strategic initiatives, as evidenced by record revenue growth and increased guidance. Technical indicators also show positive market momentum. However, profitability challenges impact the valuation score, and the company must navigate market access issues and salesforce turnover. Recent corporate events further strengthen the company's strategic positioning.
Positive Factors
Financial Performance
ANIP reported earnings highlighted by a consensus beat on revenue and adj. EBITDA and an incremental raise to 2025 guidance, driven primarily by the generics segment.
Market Expansion
Cortrophin Gel continues to gain market share from Acthar Gel and drives market expansion, including in label indications not covered by Acthar.
Product Innovation
The launch of a pre-filled syringe for Cortrophin Gel is part of ANIP's ongoing investment in commercial scale-up and product presentations.
Negative Factors
Competitive Challenges
The potential positive implication of the litigation for ANIP continues to fly under the radar, posing a challenge to stock valuation.
Legal Dispute
ANIP is currently in a legal dispute regarding the rights to receive a 5% royalty from CGON's cretostimogene sales.
Unrealized Potential
Royalties from creto, which could be a blockbuster product in bladder cancer, are not yet reflected in ANIP's stock.

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

ANI Pharmaceuticals Business Overview & Revenue Model

Company DescriptionANI Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceuticals. Operating primarily in the United States, the company offers a diverse portfolio that spans several therapeutic areas, including oncology, hormones, and pain management. ANI Pharmaceuticals is known for its robust manufacturing capabilities and commitment to addressing unmet medical needs.
How the Company Makes MoneyANI Pharmaceuticals generates revenue through the production and sale of both branded and generic prescription drugs. The company's revenue streams are primarily driven by its generic pharmaceutical products, which are sold through a network of wholesalers, distributors, and direct sales channels. ANI also earns income from its branded pharmaceuticals business, which includes specialty products that are marketed directly to healthcare professionals. Additionally, the company engages in strategic partnerships and collaborations to enhance its product offerings and expand its market reach, contributing to its overall earnings.

ANI Pharmaceuticals Earnings Call Summary

Earnings Call Date:May 09, 2025
(Q1-2025)
|
% Change Since: -6.65%|
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 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
72
Positive
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
65
Positive
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
78
Positive
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.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue674.07M614.38M486.82M316.38M216.14M208.47M
Gross Profit385.28M364.17M305.30M177.60M115.53M121.32M
EBITDA76.14M79.15M106.60M48.07M-1.68M29.07M
Net Income-21.05M-18.52M18.78M-47.90M-42.60M-22.55M
Balance Sheet
Total Assets1.29B1.28B904.42M760.09M771.60M461.19M
Cash, Cash Equivalents and Short-Term Investments149.80M151.17M221.12M48.23M100.30M7.86M
Total Debt317.53M624.09M285.67M286.52M287.37M185.69M
Total Liabilities848.96M855.17M446.82M421.55M412.86M265.49M
Stockholders Equity418.62M428.53M457.60M338.54M358.74M195.70M
Cash Flow
Free Cash Flow68.37M47.06M100.45M-47.66M-20.32M-53.05M
Operating Cash Flow80.74M64.02M118.96M-31.20M3.32M15.27M
Investing Cash Flow-433.50M-404.72M-18.51M-15.74M-105.48M-68.32M
Financing Cash Flow274.76M264.94M67.44M-5.13M194.59M-1.44M

ANI Pharmaceuticals Technical Analysis

Technical Analysis Sentiment
Positive
Last Price66.77
Price Trends
50DMA
63.18
Positive
100DMA
64.84
Positive
200DMA
61.18
Positive
Market Momentum
MACD
0.70
Negative
RSI
56.09
Neutral
STOCH
61.40
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 66.77 is above the 20-day moving average (MA) of 65.63, above the 50-day MA of 63.18, and above the 200-day MA of 61.18, indicating a bullish trend. The MACD of 0.70 indicates Negative momentum. The RSI at 56.09 is Neutral, neither overbought nor oversold. The STOCH value of 61.40 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 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 (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
75
Outperform
$1.03B26.4619.23%17.17%-51.97%
75
Outperform
$1.45B-5.19%30.26%-173.36%
71
Outperform
$1.85B29.856.32%11.82%
68
Neutral
$1.07B8.2119.90%8.05%-8.46%
60
Neutral
$1.03B-12.27%3.08%-247.82%
53
Neutral
$1.34B64.45-10.45%24.76%-783.38%
52
Neutral
$7.60B0.10-62.94%2.08%16.16%0.34%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ANIP
ANI Pharmaceuticals
66.77
4.74
7.64%
DVAX
Dynavax
11.16
-0.32
-2.79%
PCRX
Pacira Pharmaceuticals
21.82
1.84
9.21%
SUPN
Supernus Pharmaceuticals
32.85
2.17
7.07%
AMPH
Amphastar Pharmaceuticals
22.51
-19.63
-46.58%
COLL
Collegium Pharmaceutical
32.11
-3.31
-9.35%

ANI Pharmaceuticals Corporate Events

Product-Related AnnouncementsBusiness Operations and Strategy
ANI Pharmaceuticals Reveals NEW DAY Study Results
Positive
Jul 23, 2025

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.

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.

Product-Related Announcements
ANI Pharmaceuticals Reports on NEW DAY Clinical Trial Results
Neutral
Jul 23, 2025

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.

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 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.Date of analysis: Jul 24, 2025