Core Viewpoint - ANI Pharmaceuticals, Inc. has launched Nitazoxanide Tablets, a generic version of Alinia®, highlighting its commitment to providing affordable, high-quality medicines [1][2]. Company Overview - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics, with a mission of "Serving Patients, Improving Lives" [3]. - The company aims for sustainable growth through its Rare Disease business, Generics business, and Brands business [3]. Product Launch Details - The newly launched Nitazoxanide Tablets are 500 mg and represent a niche product with limited competition [1]. - U.S. annual sales for Nitazoxanide Tablets are approximately $36.1 million, based on December 2024 moving annual total (MAT) IQVIA data [2]. Partnership Information - ANI Pharmaceuticals has partnered with Biophore India Pharmaceuticals Pvt. Ltd. for the launch of Nitazoxanide Tablets, emphasizing a shared commitment to affordable medicines [2][4].

Core Points - ANI Pharmaceuticals, Inc. has completed the buyout of its 3.125% perpetual royalty obligation to SWK Funding LLC for a one-time payment of $17.25 million, eliminating future royalty payments on net revenues of ILUVIEN and YUTIQ starting January 1, 2025 [1][2] - The buyout enhances ANI's financial flexibility and supports the growth of its Retina portfolio, aligning with the company's mission of "Serving Patients, Improving Lives" [2] Company Overview - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics across various therapeutic areas, including ophthalmology, rheumatology, nephrology, neurology, and pulmonology [2] - The company aims for sustainable growth through its Rare Disease business, Generics business, and Brands business [2]

Core Viewpoint - ANI Pharmaceuticals has received FDA approval for an expanded label for ILUVIEN, which now includes treatment for chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to its existing indication for diabetic macular edema (DME) [1][4] Company Developments - The company plans to market ILUVIEN for chronic NIU-PS alongside DME in the U.S. later this year [4] - ANI has extended its supply agreement with Siegfried Holding AG for ILUVIEN through 2029, which includes upgrades to manufacturing equipment and significant capacity expansion [2] Product Indications - ILUVIEN is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye and diabetic macular edema [3][5] Safety Information - ILUVIEN has contraindications for patients with active or suspected ocular infections, glaucoma with cup to disc ratios greater than 0.8, and known hypersensitivity to any components of the product [5] - Adverse reactions reported in clinical trials include cataracts (82% for DME), increased intraocular pressure (34% for DME), and various ocular and non-ocular reactions [6][7] Clinical Trial Data - In trials for DME, 34% of ILUVIEN patients experienced an increase in intraocular pressure of 10 mm Hg or more, compared to 10% of sham patients [6] - For chronic NIU-PS, ocular adverse reactions included cataract (56%), reduced visual acuity (15%), and macular edema (11%) [7][8] Company Overview - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics across various therapeutic areas, including ophthalmology [12]

The U.S. stock market, after a stellar run in 2023 and 2024, hit a rough patch in early 2025. February saw a sharp pullback, with the S&P 500 tumbling 1.4% and extending losses into March. Investors are becoming increasingly wary of the economic impact of Trump’s tariff policies, which could fuel inflation and slow down growth. The Federal Reserve has held off on further rate cuts, adding to market uncertainty. Meanwhile, concerns of a near-term recession have resurfaced, with the Atlanta Fed projecting a 2 ...

Financial Projections - Total company net revenues for 2024 are expected to be between $739 million and $759 million, reflecting a compound annual growth rate (CAGR) of approximately 33% from 2022 to 2025[10]. - Adjusted non-GAAP EBITDA for 2024 is projected to be between $182 million and $192 million, indicating a CAGR of around 50% from 2022 to 2025[14]. - Projected revenues for 2024 are estimated to be between $594 million and $602 million, representing a year-over-year growth of 22-24%[57]. - Adjusted non-GAAP EBITDA for the three months ended September 30, 2024, was $35.1 million, a decrease from $133.8 million for the same period in 2023[60]. - Adjusted non-GAAP EBITDA for the nine months ended September 30, 2024, was $106 million, down from $134 million for the same period in 2023[60]. - Adjusted non-GAAP net income available to common shareholders for the three months ended September 30, 2024, was $26.5 million[61]. Rare Disease Segment - Cortrophin Gel, the lead rare disease asset, achieved nearly $200 million in sales during its third year post-launch[10]. - Rare disease net revenues are projected to grow by 133% from 2022 to 2024, reaching between $228 million and $229 million[18]. - The ACTH market is estimated to be worth $600 million at launch in 2022 and approximately $670 million in 2024, driven by Cortrophin Gel's introduction[23]. - The company expects continued strong growth in the rare disease segment, supported by high barriers to entry and limited competition[22]. - Preliminary results for Q4 2024 indicate a 107% year-over-year increase in revenues from the rare disease segment[12]. - Cortrophin Gel achieved approximately $198 million in revenue for 2024, indicating a strong multi-year growth trajectory[56]. - Cortrophin's use for acute gouty arthritis flares has grown to approximately 15% of its total usage, with a significant addressable patient population of around 300,000[31]. - The company expects its Rare Disease business to account for over 50% of total revenues by 2025, driving future growth[54]. Product Launches and Acquisitions - The acquisition of Alimera expanded the rare disease franchise, contributing to the growth of the portfolio[10]. - The acquisition of Alimera Sciences is projected to contribute $10 million in synergies by 2025, enhancing the company's ophthalmology portfolio[33]. - A total of 17 new generic products were launched in 2024, maintaining a 2 ranking in Competitive Generic Therapy (CGT) approvals[10]. - ANI Pharmaceuticals has launched seventeen new products in 2024, including two Competitive Generic Therapy products with 180-day exclusivity[52]. - The company plans to launch a Pre-Filled Syringe for Cortrophin Gel in the first half of 2025, enhancing patient convenience[56]. - The expanded ophthalmology sales team has increased new patient starts in this area by approximately 2x quarter-over-quarter in Q4[27]. Financial Health and Expenses - ANI Pharmaceuticals has maintained a disciplined approach towards debt levels, with a post-acquisition net leverage of 3.0x[57]. - Net loss for the three months ended September 30, 2024, was $(24.2) million, compared to a net income of $18.8 million for the same period in 2023[60]. - Cash and cash equivalents increased significantly from $48 million in 2022 to $221 million in 2023[63]. - Net debt decreased from $249 million in 2022 to $73 million in 2023, resulting in a net debt/EBITDA ratio of 0.5x[63]. - The gross debt remained relatively stable at $294 million in 2023 compared to $297 million in 2022[63]. - The company incurred $9.9 million in M&A transaction expenses during the three months ended September 30, 2024[61]. - Stock-based compensation for the three months ended September 30, 2024, amounted to $7.5 million[61]. - Depreciation and amortization expenses for the three months ended September 30, 2024, were $15.7 million[61].

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 ...