Generated record quarterly net revenues of $138.0 million, representing year-over-year growth of 18.4%, and record Rare Disease net revenues of $49.2 million, an increase of 102.4% year-over-yearDelivered adjusted non-GAAP EBITDA of $33.2 million, and adjusted non-GAAP diluted earnings per share of $1.02Net loss available to common shareholders of $(2.7) million and diluted GAAP loss per share of $(0.14)On track to close acquisition of Alimera Sciences, Inc. in the third quarter of 2024, adding two durable ...

Generated record quarterly net revenues of $138.0 million, representing year-over-year growth of 18.4%, and record Rare Disease net revenues of $49.2 million, an increase of 102.4% year-over-yearDelivered adjusted non-GAAP EBITDA of $33.2 million, and adjusted non-GAAP diluted earnings per share of $1.02Net loss available to common shareholders of $(2.7) million and diluted GAAP loss per share of $(0.14)On track to close acquisition of Alimera Sciences, Inc. in the third quarter of 2024, adding two durable ...

Fokusiert/iStock via Getty ImagesAni Pharmaceuticals (NASDAQ:ANIP) had not provided any details on their three 505(b)(2) NDA submissions currently being reviewed by the FDA. Therefore, analysts have excluded their revenue potential in assessing ANIP’s growth outlook. On ANIP has yet to announce that on July 29, 2024 the FDA approved Tezruly as the first oral solution of terazosin. Tezruly's related patent expires February 1, 2041. Based on ANIP’s SEC filings, patent applications and clinical trial infor ...

PRINCETON, N.J., July 15, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Powder. ANI's L-Glutamine Oral Powder is the generic version of the reference listed drug (RLD) Endari®. "The approval and launch of L-Glutamine Oral Powder, the first AA-rated approved generic to Endari®, continues to ...

PRINCETON, N.J., July 02, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) and launched Naproxen Delayed-Release Tablets, USP. ANI's Naproxen Delayed-Release Tablets is the generic version of the reference listed drug (RLD) EC-Naprosyn®. "We are pleased to announce the first cycle FDA approval and commercialization of Naproxen Delayed-Release ...

Core Viewpoint - ANI Pharmaceuticals, Inc. has received FDA approval for its Naproxen Delayed-Release Tablets, marking a significant milestone in the company's product launch strategy and commitment to growth [1]. Company Overview - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, particularly for diseases with high unmet medical needs [2]. - The company aims to achieve sustainable growth by expanding its Rare Disease business, enhancing its Generics business through improved R&D capabilities, and leveraging its U.S.-based manufacturing [2]. Product Launch and Market Potential - The FDA approval pertains to the Abbreviated New Drug Application (ANDA) for Naproxen Delayed-Release Tablets, which is a generic version of EC-Naprosyn® [1]. - The U.S. annual sales for Naproxen Delayed-Release Tablets are approximately $36.7 million, based on April 2024 moving annual total (MAT) IQVIA data [1].

PRINCETON, N.J., June 25, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that its Chief Executive Officer, Nikhil Lalwani, has been named an Ernst & Young LLP (EY US) Entrepreneur Of The Year® 2024 New Jersey Award winner. Entrepreneur Of The Year is the preeminent competitive awards program for entrepreneurs and leaders of high-growth companies. Mr. Lalwani was selected by an independent judging panel made up of previous award winners, leading CEOs, a ...

PRINCETON, N.J., June 25, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that its Chief Executive Officer, Nikhil Lalwani, has been named an Ernst & Young LLP (EY US) Entrepreneur Of The Year® 2024 New Jersey Award winner. Entrepreneur Of The Year is the preeminent competitive awards program for entrepreneurs and leaders of high-growth companies. Mr. Lalwani was selected by an independent judging panel made up of previous award winners, leading CEOs, ...

Conference call scheduled for today at 8:30 a.m. ET Strengthens Rare Disease segment as largest driver of future growth, expected to add approximately $105 million in highly durable branded revenueAdds two commercial assets ILUVIEN® and YUTIQ® with significant growth potential, expanding ANI’s foothold in key strategic therapeutic area of ophthalmology Anticipated to drive high single digit to low double digit accretion in adjusted non-GAAP EPS in 2025 and to be substantially accretive thereafterExpected to ...

JHVEPhoto/iStock Editorial via Getty Images Since Ani Pharmaceuticals (NASDAQ:ANIP) merged with Biosante Pharmaceuticals in 2013, ANIP's growth has largely been fueled by M&A, the most important of which are the acquisition Purified Cortrophin Gel from Merck & Co., Inc. (MRK) in 2016 and the merger with Novitium Pharma in 2021. The market sees these as drivers of ANIP's growth, and analyst estimates currently reflect this. However, ANIP's royalty revenue potential is largely unnoticed. This article looks at ...