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) 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.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) is set to release its first quarter 2021 financial results on May 7, 2021. The announcement will be followed by a conference call hosted by President and CEO Nikhil Lalwani and CFO Stephen P. Carey at 8:30 a.m. ET. Investors can join via a toll-free number or through a live webcast, which will also be available for replay. ANI focuses on developing and marketing high-quality prescription pharmaceuticals, including niche segments such as oncology and controlled substances.
ANI Pharmaceuticals (NASDAQ:ANIP) has acquired the NDAs for OXISTAT® Lotion, VEREGEN® Ointment, Pandel® Cream, and the ANDA for ApexiCon® E Cream from Sandoz Inc. These products generated net revenues of $13.2 million in 2020. The acquisition is funded via borrowings from the company's credit facility. ANI and Sandoz also entered a multi-year manufacturing agreement for the products, which ANI plans to manufacture in-house in the future. This aligns with ANI's strategy of expanding its established brands business.
ANI Pharmaceuticals (NASDAQ: ANIP) reported its business highlights and financial results for Q4 and the full year 2020. Key achievements include a definitive agreement to acquire Novitium Pharma for $163.5 million, expected to enhance earnings within a year. Q4 net revenues increased to $57.3 million, up from $48.0 million in Q4 2019. However, the company reported a GAAP net loss of $3.6 million in Q4 2020, with a diluted loss per share of $0.30. Full-year 2020 revenues were $208.5 million, slightly up from 2019. ANI aims to boost its growth strategy with a focus on Cortrophin and generics.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has finalized an agreement to acquire Novitium Pharma for $163.5 million, comprising $89.5 million in cash and $74 million in equity. The acquisition aims to enhance ANI's generics business and R&D capabilities, with a focus on niche opportunities. Expected to close in H2 2021, pending regulatory approvals, the deal is projected to be immediately accretive to adjusted EBITDA, contributing approximately $15 million to adjusted EBITDA within the first year. The transaction is supported by new financing, including a $300 million Term Loan B.
ANI Pharmaceuticals announced the grant of non-qualified inducement stock options totaling 60,764 shares to two executives, Ori Gutwerg and Christopher Mutz, effective February 15, 2021. These options were provided as employment inducements in line with Nasdaq rules and will vest annually over four years. The options have an exercise price of $31.49 per share, matching the stock's closing price on February 12, 2021. They also feature acceleration clauses in case of a change in control or certain employment terminations.
ANI Pharmaceuticals announced the hiring of three key executives: Christopher K. Mutz as Chief Commercial Officer and Head of Rare Diseases, Ori Gutwerg as Senior Vice President of Generics, and Davinder Singh as General Manager of Canadian Operations. These additions are set to enhance ANI's leadership team to accelerate growth across its business units. Additionally, Robert Schrepfer, Senior VP of Business Development, will leave the company next month for another opportunity.
ANI Pharmaceuticals (NASDAQ: ANIP) will announce its fourth quarter and full year 2020 financial results on March 9, 2021. Nikhil Lalwani, President and CEO, along with Stephen P. Carey, CFO, will lead a conference call at 8:30 a.m. ET to discuss the results. Interested parties can join the call via a toll-free number or listen to a live webcast on the company’s website. A replay of the call will be available shortly after its conclusion, accessible for one week.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) has launched Prazosin HCl Capsules USP in 1mg and 2mg, following FDA approval of its prior approval supplement application. The U.S. market for these strengths is approximately $46.2 million, as per IQVIA/IMS Health. This marks ANI's fourteenth re-commercialization of a discontinued ANDA product, showcasing its commitment to maximizing product portfolio value. Prazosin is used to treat hypertension, thereby reducing cardiovascular event risks, including strokes and heart attacks.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) has received FDA approval for Aminocaproic Acid Tablets USP, 500mg, marking its seventh generic product launch in 2020. The U.S. market for this product is valued at approximately $12.7 million, highlighting its significance in enhancing hemostasis during bleeding situations. This launch is part of ANI's strategy to accelerate its product introductions, stemming from its acquisition of a generic pipeline from Amerigen Pharmaceuticals. The company anticipates more product launches in the future, focusing on realizing its portfolio potential.
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