ANI Pharmaceuticals (ANIP) closed the last trading session at $61.05, gaining 1.4% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $80.83 indicates a 32.4% upside potential.The average comprises six short-term price targets ranging from a low of $62 to a high of $94, with a standard deviation of $10.52. While the lowest estimate indicates an increase of 1.6% from the current price ...

Growth investors focus on stocks that are seeing above-average financial growth, as this feature helps these securities garner the market's attention and deliver solid returns. But finding a great growth stock is not easy at all.In addition to volatility, these stocks carry above-average risk by their very nature. Also, one could end up losing from a stock whose growth story is actually over or nearing its end.However, the task of finding cutting-edge growth stocks is made easy with the help of the Zacks Gr ...

Investors might want to bet on ANI Pharmaceuticals (ANIP) , as it has been recently upgraded to a Zacks Rank #1 (Strong Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following yea ...

Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. ANI Pharmaceuticals (ANIP) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.ANI Pharmaceuticals is a member of the Medical sector. This group includes 1012 individual stocks ...

PRINCETON, N.J., March 03, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced U.S. Food and Drug Administration (FDA) approval of Purified Cortrophin® Gel (repository corticotropin injection USP) (Cortrophin Gel) in a prefilled syringe format. This new presentation will be available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options through Cortrophin Gel’s established specialty pharmacy network. The prefilled syringe reduces administration ste ...

Financial Data and Key Metrics Changes - ANI Pharmaceuticals reported record fourth quarter and full year 2024 results, raising 2025 guidance for total revenues and adjusted non-GAAP EBITDA [10][11] - 2025 revenue is now expected to be between $756 million and $776 million, representing growth of 23% to 26% over 2024 [10][62] - Adjusted non-GAAP EBITDA for 2025 is projected to be between $190 million and $200 million, reflecting growth of 22% to 28% over 2024 [10][62] Business Line Data and Key Metrics Changes - Rare Disease was the primary growth driver in 2024, with Cortrophin Gel generating close to $200 million in sales [11][12] - Generics business achieved 12% revenue growth, marking the third consecutive year of double-digit growth [12] - Fourth quarter revenues for Rare Disease and Brands were $106.9 million, up 97% year-over-year, with Rare Disease revenues more than doubling to $87 million [53][55] Market Data and Key Metrics Changes - The overall ACTH market is expected to have grown about 25% to approximately $660 million in 2024 [38] - There are currently fewer than 5,000 patients on therapy for ILUVIEN and YUTIQ, with an estimated addressable patient population 6 to 10 times higher [89][113] - The demand for Cortrophin Gel increased across all targeted specialties, including neurology, rheumatology, nephrology, pulmonology, and ophthalmology [15][35] Company Strategy and Development Direction - The company aims to broaden its presence in the rare disease space, as evidenced by the acquisition of Alimera Sciences [12][11] - A core strategic rationale for the Alimera acquisition was to add synergistic assets and leverage existing infrastructure to unlock the potential of ILUVIEN and YUTIQ [17][51] - The company plans to continue investing in R&D and commercial initiatives to drive growth in its Rare Disease business [45][51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth prospects for Cortrophin Gel and the overall ACTH market, despite current access issues for ILUVIEN and YUTIQ [89][114] - The company anticipates a typical Q4 to Q1 revenue drop for Cortrophin Gel, followed by strong sequential growth in subsequent quarters [63][90] - Management highlighted the importance of addressing unmet needs in autoimmune disorders and the potential for significant market expansion [39][40] Other Important Information - The company has expanded its U.S. ophthalmology sales team from 30 to 46 representatives to promote ILUVIEN, YUTIQ, and Cortrophin Gel [20][48] - A prefilled syringe for Cortrophin Gel is under FDA review, expected to launch in the second quarter of 2025 [44][45] - The company has taken steps to enhance supply security for ILUVIEN and YUTIQ through partnerships and capacity expansions [22][100] Q&A Session Summary Question: Business development and M&A capacity - Management indicated a thoughtful approach to leverage ratios, historically keeping it under three, and expressed intent to pursue additional business development while maintaining balance sheet health [76][78] Question: Gout's contribution to Cortrophin sales - Currently, 15% of Cortrophin's volume comes from gout, which is seen as a gateway indication for new prescribers [80] Question: Access issues for Alimera assets - Management acknowledged access issues for ILUVIEN and YUTIQ due to funding shortfalls in patient assistance programs but remains confident in long-term growth prospects [88][89] Question: Seasonality impact on Cortrophin - Typical Q4 to Q1 dynamics are expected, with a drop in sales followed by sequential growth, supported by strong early trends [90] Question: Transitioning supply from EyePoint to Siegfried - Management confirmed that supply transitions are being managed carefully, with inventory buildup and a focus on maintaining supply security [100][101]

For the quarter ended December 2024, ANI Pharmaceuticals (ANIP) reported revenue of $190.57 million, up 44.8% over the same period last year. EPS came in at $1.63, compared to $1.00 in the year-ago quarter.The reported revenue represents a surprise of +8.98% over the Zacks Consensus Estimate of $174.88 million. With the consensus EPS estimate being $1.44, the EPS surprise was +13.19%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to W ...

ANI Pharmaceuticals (ANIP) Q4 2024 Earnings Call February 28, 2025 08:00 AM ET Company Participants Lisa Wilson - Founder and PresidentNikhil Lalwani - President and CEOChristopher Mutz - Senior Vp & Head of Rare DiseaseStephen Carey - Senior VP of Finance & CFOGary Nachman - Managing Director - Equity ResearchJeevan Larson - Equity Research AssociateGlen Santangelo - Managing Director Conference Call Participants David Amsellem - Sr. Research AnalystVamil Divan - Managing Director & Senior Research Analyst ...

Competition and Market Dynamics - The company faces competition from numerous pharmaceutical companies, including large global manufacturers, and generic products [109]. - The wholesale distributor network has seen increasing consolidation, leading to pricing pressure and a shift in sales to competitors [112]. - The company faces substantial competition from major pharmaceutical and biotechnology companies, which could adversely affect profitability and market share [131]. - The approval of generic products often leads to immediate competition, resulting in lower prices and reduced margins, which could adversely affect profitability [163]. - The concentration of net revenues among four customers, which accounted for 64% of total revenues in 2024, poses risks related to customer consolidation and pricing pressures [236]. Financial Performance and Risks - The company expects to spend significant resources on research and development, which may not result in marketable products [128]. - The company is subject to risks related to product liability claims that may not be covered by insurance [128]. - Medicaid rebate accruals have significantly increased due to acquisitions and sales of branded products, which could adversely affect the company's financial position and operating results [166]. - Accruals for the Medicare Coverage Gap Discount Program have also increased, potentially decreasing revenues from product sales and impacting the company's financial health [167]. - The company faces complex reporting obligations under the Medicaid rebate program, with potential penalties for non-compliance that could adversely affect financial results [237]. Regulatory and Compliance Challenges - The company may face legal and regulatory challenges, including false claims litigation, which could result in significant penalties [131]. - The company is subject to various U.S. laws, including the Anti-Kickback Statute and false claims laws, which could lead to significant penalties and affect operations [148]. - Increased enforcement activities by agencies like the FDA and DOJ could result in investigations that adversely impact the company's financial condition and operations [149]. - Compliance with FDA regulations and potential violations could lead to sanctions, including fines and product recalls, impacting business operations [257]. - The company is subject to extensive regulations governing the use and disposal of hazardous materials, which may incur significant compliance costs [259]. Research and Development - The company expects to invest significantly in research and development, but there is no guarantee that these efforts will result in marketable products, which could adversely affect financial results [168]. - The company faces risks related to the timely development and commercialization of new products, which are critical for future revenue growth and profitability [160]. - Clinical trials, such as the NEW DAY trial for ILUVIEN, may fail to demonstrate efficacy or take longer than anticipated, which could negatively impact the company's financial condition and cash flows [171]. - The company relies on third parties for clinical trials, and any failure in their performance could delay or terminate trials, affecting regulatory approval and commercialization [172]. Workforce and Diversity - The company’s workforce consists of 897 employees, with 720 located in the U.S. and 177 in other countries [118]. - Approximately 42% of the workforce identified as female and 45% identified as a person of color or indigenous person as of the end of 2024 [120]. Mergers and Acquisitions - The acquisition of Alimera was completed on September 16, 2024, with anticipated benefits including enhanced revenues and a strengthened market position [210]. - The merger has materially increased the size of operations, and effective management of these expanded operations is crucial to avoid adverse effects on stock price [211]. - The company faces significant costs and expenses related to the merger, including professional services and transaction costs, which may affect liquidity and cash flow [213]. - The success of the combined company will depend on maintaining relationships with third parties and customers, which may be affected by public attitudes towards the merger [211]. Supply Chain and Manufacturing - The company relies on third-party manufacturers for many products, which poses risks related to compliance and production delays [141]. - The company operates three manufacturing facilities, and any disruption could impair production and shipping, leading to potential "failure to supply" claims from customers [169]. - The company is dependent on imported active pharmaceutical ingredients (APIs), and any disruptions in supply or increased costs could materially impact revenues and operations [243]. - The DEA regulates the supply of APIs for controlled substances, and any inability to obtain necessary approvals could significantly reduce revenues from these products [245]. Legal and Intellectual Property Risks - The company faces risks related to climate change, which could disrupt operations and adversely affect client activity levels and creditworthiness [175]. - There is a risk of litigation regarding patent infringement, which could divert resources and delay product commercialization [192]. - The company may need to seek licenses from third parties due to potential patent infringement claims, which could impose significant costs [194]. - The company's success largely depends on the ability to obtain and maintain intellectual property protection, which is uncertain in the biotechnology and pharmaceuticals field [188]. Financial Obligations and Debt - As of December 31, 2024, the company had approximately $639.2 million in indebtedness and other liabilities on a consolidated basis [284]. - The New Credit Agreement includes a $325.0 million term loan and a $75.0 million revolving credit facility, secured by all assets [285]. - The company may struggle to repurchase Senior Notes or pay cash amounts due upon maturity or conversion, potentially leading to defaults [293]. - The New Credit Agreement includes restrictive covenants that limit the company's operational flexibility and ability to incur additional debt [287]. Market and Economic Conditions - The company faces risks from international operations, including economic conditions and geopolitical tensions, which could adversely affect business results [262]. - Inflationary pressures may significantly increase input costs, which the company may not be able to pass on to customers [270]. - Changes in third-party payer coverage and reimbursement practices may hinder the company's ability to market products effectively [254].

Core Insights - ANI Pharmaceuticals reported strong financial results for Q4 and full year 2024, exceeding previous guidance in total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS [2][9][12] - The company raised its 2025 guidance for total net revenues and adjusted non-GAAP EBITDA, reflecting confidence in continued growth, particularly in its Rare Disease and Generics segments [2][21] Financial Performance - Total net revenues for Q4 2024 reached $190.6 million, a 44.8% increase year-over-year, with organic growth of 23.8% excluding the Alimera acquisition [12][9] - Rare Disease segment revenues increased 108.5% to $87.0 million, driven by Cortrophin Gel sales of $59.4 million, up 42.3% year-over-year [13][11] - Generics revenues grew 9.4% to $78.6 million, supported by strong R&D capabilities and five new product launches in the quarter [8][14] Segment Highlights - Cortrophin Gel continues to show strong growth, with increasing demand across multiple specialties and a significant number of new patient starts [3][4] - The acquisition of Alimera Sciences contributed $27.6 million in revenues from ILUVIEN and YUTIQ in their first full quarter of ownership [5][13] - Brand revenues increased 58.9% to $19.8 million, driven by sustained demand for certain products [7][11] Guidance and Future Outlook - For 2025, the company expects total net revenues between $756 million and $776 million, with adjusted non-GAAP EBITDA projected at $190 million to $200 million [21][22] - Cortrophin Gel net revenues are anticipated to be between $265 million and $274 million, reflecting year-over-year growth of 33.8% to 38.3% [21][9] - The company plans to expand the market for ILUVIEN by seeking FDA approval for additional indications [6][5] Operational Metrics - Adjusted non-GAAP EBITDA for Q4 2024 was $50.0 million, a 65.7% increase from the previous year [19][9] - The company reported a diluted GAAP loss per share of $(0.55) but an adjusted non-GAAP diluted EPS of $1.63, up from $1.00 in the prior year [18][9] - As of December 31, 2024, ANI had $144.9 million in unrestricted cash and cash equivalents, with total assets of $1.28 billion [20][49]