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 (Nasdaq: ANIP) has announced the FDA approval and launch of L-Glutamine Oral Powder, the first AA-rated generic version of Endari®. This approval showcases the company's strong R&D capabilities and execution. The product aims to provide patients and healthcare providers with access to high-quality therapeutics.
Key points:
- L-Glutamine Oral Powder is an Abbreviated New Drug Application (ANDA)
- U.S. annual sales for the product are approximately $20.1 million (based on May 2024 IQVIA data)
- The launch demonstrates ANI's commitment to expanding its product portfolio and addressing market needs
ANI Pharmaceuticals has announced the FDA approval and launch of Naproxen Delayed-Release Tablets, USP, which is a generic version of EC-Naprosyn®. This product received first-cycle approval, allowing ANI to quickly commercialize it.
The U.S. market for Naproxen Delayed-Release Tablets is valued at approximately $36.7 million annually, based on April 2024 IQVIA data. Nikhil Lalwani, President and CEO of ANI, emphasized the company's commitment to growth through effective new product launches.
ANI Pharmaceuticals announced that its CEO, Nikhil Lalwani, has won the EY Entrepreneur Of The Year 2024 New Jersey Award. The award, given by Ernst & Young LLP, recognizes outstanding entrepreneurial vision, leadership, and impact on patients and growth. Lalwani, CEO since September 2020, has increased the company's Enterprise Value by 2.8 times. This award makes Lalwani eligible for the National and World Entrepreneur Of The Year Awards. The program highlights leaders who have significantly transformed their organizations.
ANI Pharmaceuticals announced the acquisition of Alimera Sciences to expand its Rare Disease segment, which will drive future growth.
The acquisition involves $5.50 per share in cash and contingent value rights of up to $0.50 per share, valuing Alimera at $381 million.
This deal adds $105 million in branded revenue and is expected to strengthen ANI's ophthalmology portfolio with ILUVIEN and YUTIQ.
The acquisition is projected to contribute $35-$38 million in 2025 adjusted non-GAAP EBITDA and $10 million in cost synergies.
ANI expects high single-digit to low double-digit accretion in adjusted non-GAAP EPS in 2025, with further growth thereafter.
The transaction is anticipated to close in Q3 2024, subject to regulatory and shareholder approvals.
ANI Pharmaceuticals announced that CEO Nikhil Lalwani will present at the 2024 Jefferies Global Healthcare Conference in New York City. The presentation is scheduled for June 5, 2024, at 4:30 PM ET. Interested parties can attend the webcast through a provided link or schedule 1-on-1 meetings by contacting their Jefferies representative.
ANI Pharmaceuticals announced the launch of Kionex® Suspension, a Sodium Polystyrene Sulfonate Suspension USP, for oral or rectal use. This product is the only commercially available therapeutically equivalent to the reference listed drug (RLD) SPS® Suspension. The launch highlights ANI's capability to introduce complex generics with market competition. According to President and CEO Nikhil Lalwani, this achievement demonstrates the company's strong R&D team and their ability to meet FDA's updated guidelines. The U.S. annual sales for this drug category total approximately $30.3 million, based on March 2024 IQVIA data.
ANI Pharmaceuticals reported record first quarter 2024 financial results with net revenues of $137.4 million, up 28.7% year-over-year, net income of $17.8 million, and GAAP EPS of $0.82. Rare Disease business saw significant growth with $36.9 million in net revenues. ANI reiterated 2024 guidance of $520-$542 million in net revenues, $135-$145 million in adjusted non-GAAP EBITDA, and $4.26-$4.67 in adjusted non-GAAP EPS.
ANI Pharmaceuticals, Inc. (ANIP) announced that its CEO and CFO will participate in two upcoming healthcare conferences in New York City. The first event is Capital One 1st Annual Biotech/Biopharma Disruptors on May 14, 2024, and the second is H.C. Wainwright 2nd Annual BioConnect Conference at NASDAQ on May 20, 2024. Investors can schedule 1x1 meetings with management via provided contacts. The webcast of the events will be available on ANIP's website for 90 days.
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