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BAUDETTE, Minn. - ANI Pharmaceuticals, Inc. (NASDAQ:ANIP), a biopharmaceutical company with a market capitalization of $1.25 billion and strong revenue growth of 26.2% over the last twelve months, announced today that the U.S. Food and Drug Administration (FDA) has approved an updated label for ILUVIEN, a fluocinolone acetonide intravitreal implant, to include treatment for chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). This approval expands the drug’s use beyond its existing indication for diabetic macular edema (DME).
ANI plans to begin marketing ILUVIEN under the new combined label in the U.S. later this year. The product is already approved for both DME and NIU-PS in seventeen European countries. The label update also includes modifications to the Warnings and Precautions section. According to InvestingPro data, five analysts have recently revised their earnings estimates upward for the upcoming period, suggesting positive market reception of this development.
Nikhil Lalwani, President and CEO of ANI, emphasized the benefits of the expanded label for ILUVIEN and the company’s strengthened partnership with Seigfried, the contract manufacturer for ILUVIEN. The extended supply agreement with Seigfried through 2029 and enhancements to manufacturing capacity aim to improve supply security and patient access.
ILUVIEN is contraindicated for patients with certain ocular infections, glaucoma with high cup to disc ratios, and known hypersensitivity to any of the product’s components. The updated label includes warnings about potential side effects from intravitreal injections, such as endophthalmitis, eye inflammation, and changes in intraocular pressure, as well as the risks associated with prolonged corticosteroid use like glaucoma and cataracts.
Adverse reactions observed in clinical trials for DME include cataract formation and increased intraocular pressure, which sometimes required surgical intervention. For NIU-PS, cataracts, reduced visual acuity, and increased intraocular pressure were also reported.
ANI Pharmaceuticals is a biopharmaceutical company focused on developing, manufacturing, and commercializing high-quality therapeutics. The company’s growth strategy includes its Rare Disease business, Generics business, and Brands business. InvestingPro analysis indicates the company maintains strong liquidity with a current ratio of 2.72, while receiving an overall Financial Health Score of "GREAT." For detailed insights into ANI’s valuation and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
This news is based on a press release statement and is intended for informational purposes only. The information presented is not an endorsement of ILUVIEN or ANI Pharmaceuticals. The company’s next earnings report is scheduled for May 7, 2025, where investors can expect updates on ILUVIEN’s market performance and overall business growth. For more comprehensive financial analysis and additional ProTips, visit InvestingPro.
In other recent news, ANI Pharmaceuticals reported fourth-quarter earnings that surpassed analyst expectations, with adjusted earnings per share at $1.63, beating the estimate of $1.45. The company’s revenue for the quarter reached $190.6 million, exceeding the consensus estimate of $175.12 million and marking a 44.8% increase year-over-year. The Rare Disease segment played a significant role in this growth, with Cortrophin Gel contributing $59.4 million, a 42.3% increase from the previous year. Additionally, the company has raised its 2025 revenue guidance to between $756 million and $776 million, surpassing prior forecasts.
Jefferies initiated coverage on ANI Pharmaceuticals with a Buy rating and an $80 price target, highlighting the company’s strategic shift towards branded rare disease products. JPMorgan also initiated coverage, setting an $85 price target and emphasizing the company’s strong product portfolio, including Cortrophin Gel and new acquisitions Iluvien and Yutiq. Meanwhile, Truist Securities maintained a Hold rating with a $62 target, noting the company’s strategic consolidation of its Established Brands into the "Rare Disease and Brands" segment.
Leerink Partners raised their price target for ANI Pharmaceuticals to $82, maintaining an Outperform rating following the company’s strong financial results and upward revision of 2025 guidance. The firm pointed to the potential growth of Cortrophin Gel and the strategic importance of Iluvien and Yutiq as key factors in the company’s transformation. These developments indicate a positive outlook for ANI Pharmaceuticals as it continues to expand its presence in the rare disease market.
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