Welcome to our dedicated page for ANI Pharmaceuticals news (Ticker: ANIP), a resource for investors and traders seeking the latest updates and insights on ANI Pharmaceuticals stock.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a US-based integrated specialty pharmaceutical company dedicated to developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceuticals. The company's expertise lies in targeting niche and high-barrier markets such as controlled substances, anti-cancer treatments (oncolytics), hormones and steroids, and complex formulations. ANI operates two state-of-the-art manufacturing facilities in Baudette, Minnesota, capable of producing oral solid dose products, liquids, topicals, controlled substances, and other potent products in fully-contained environments.
In recent developments, ANI Pharmaceuticals has achieved significant milestones, including the FDA approval of the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension, USP, and the launch of Pentoxifylline Extended-Release Tablets. These initiatives highlight ANI's commitment to expanding access to high-quality generics for limited competition products.
The company's flagship product, Purified Cortrophin® Gel, drives its Rare Disease segment, which has shown remarkable growth. In the first quarter of 2024, ANI reported record net revenues of $137.4 million, marking a 28.7% year-over-year increase. The Rare Disease segment alone delivered Q1 net revenues of $36.9 million, a 126.2% year-over-year growth. ANI's generics business also continues to strengthen with multiple product launches, including Baclofen Oral Suspension and Kionex® (Sodium Polystyrene Sulfonate Suspension USP) for oral or rectal use.
Financially, ANI Pharmaceuticals is on a robust growth trajectory, with 2024 guidance projecting net revenues between $520 million and $542 million and adjusted non-GAAP EBITDA between $135 million and $145 million. The company’s success is underpinned by its strategic focus on innovation, enhanced R&D capabilities, and leveraging its North American manufacturing footprint to meet market demands.
ANI Pharmaceuticals remains dedicated to its mission of
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has announced that CEO Nikhil Lalwani and CFO Stephen Carey will present at the Cantor Virtual Global Healthcare Conference on September 30, 2021, at 8:00 a.m. ET. The presentation will be available via a live webcast and archived for 30 days on the Company's website under the Investors section. ANI Pharmaceuticals is dedicated to developing, manufacturing, and marketing quality pharmaceutical products, focusing on sustainable growth through its Purified Cortrophin Gel® franchise and generics business.
ANI Pharmaceuticals has launched its generic version of Bystolic, called Nebivolol Tablets, available in 2.5 mg, 5 mg, 10 mg, and 20 mg dosages. The U.S. market for Bystolic is approximately
ANI Pharmaceuticals announced that the FDA has accepted its supplemental New Drug Application for Purified Cortrophin Gel. This is a significant milestone with a target action date set for
ANI Pharmaceuticals reported financial results for Q2 2021, with net revenues at $48.6 million, slightly up from $48.5 million in Q2 2020. The net loss for the quarter was $14.1 million, compared to $12.3 million the previous year. Key highlights include the refiling of the sNDA for Cortrophin® Gel and the ongoing acquisition of Novitium Pharma, expected to close later this year. Despite increased revenues from generic and branded products, operating expenses rose to $64.2 million, impacting profitability. The company held $24.3 million in cash and cash equivalents, with total debt of $205.7 million.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) will release its second quarter 2021 financial results on August 6, 2021. A conference call is scheduled for 8:30 a.m. ET, led by CEO Nikhil Lalwani and CFO Stephen P. Carey. Participants can join via a toll-free number or access the live webcast on the company's website. A replay will be available shortly after the call and for one week. ANI specializes in developing high-quality branded and generic pharmaceuticals, focusing on niche markets like controlled substances and oncology products.
ANI Pharmaceuticals (Nasdaq: ANIP) has re-filed its supplemental new drug application (sNDA) for Cortrophin® Gel with the FDA. CEO Nikhil Lalwani expressed satisfaction with the re-filing process, highlighting the company's extensive efforts to address previous FDA feedback through expert consultations. Cortrophin Gel is considered a key product for ANI, with hopes for market approval to benefit patients. The company specializes in developing and marketing specialty pharmaceuticals, focusing on niche markets.
ANI Pharmaceuticals will present at the Raymond James Human Health Innovation Conference on June 22, 2021, at 12:00 PM Eastern Time. The presentation, featuring CEO Nikhil Lalwani and CFO Stephen Carey, will be available via webcast and archived for 30 days. ANI focuses on delivering high-quality specialty pharmaceuticals, including controlled substances and oncology products. More about the company can be found at www.anipharmaceuticals.com.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) announced log-in details for its 2021 Virtual Annual Meeting of Stockholders on June 2, 2021, at 10 a.m. Eastern Time. Stockholders of record as of April 26, 2021, can vote and submit questions during the meeting via a provided control number. Participants can log in starting at 9:45 a.m. An annual meeting replay will be available for one year. ANI is a specialty pharmaceutical company focusing on the development and manufacturing of branded and generic prescription pharmaceuticals, including narcotics and oncolytics.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) announced that CEO Nikhil Lalwani and CFO Stephen Carey will present at the Jefferies Virtual Healthcare Conference on June 4, 2021, at 10:00 a.m. ET. The presentation will be webcast live and archived for 30 days on the Company's website. ANI is an integrated specialty pharmaceutical company focused on developing and marketing high-quality branded and generic prescription pharmaceuticals, particularly in niche markets.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) reported strong first-quarter results for 2021, achieving net revenues of $54.5 million, up from $49.8 million in Q1 2020. The company is advancing its re-filing for Cortrophin® Gel and plans to acquire Novitium Pharma LLC, a move expected to diversify its portfolio and enhance R&D. Notable FDA submissions for dermatology products from Sandoz Inc. were completed, adding approximately $13.2 million in annual revenues. Despite pandemic-related challenges, ANI's adjusted non-GAAP earnings per share stood at $1.04.
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