Welcome to our dedicated page for Ani Pharmaceutic news (Ticker: ANIP), a resource for investors and traders seeking the latest updates and insights on Ani Pharmaceutic stock.
ANI Pharmaceuticals Inc. (ANIP) delivers innovative solutions in specialty generics and complex drug formulations, focusing on therapeutic areas with high barriers to entry. This page provides investors and healthcare professionals with timely updates on regulatory milestones, manufacturing developments, and strategic initiatives within controlled substances, oncology, and rare disease therapies.
Discover official press releases covering ANIP’s FDA submissions, product launches, and financial results alongside analysis of its Minnesota-based manufacturing capabilities. Our repository includes updates on niche segments like hormonal therapies and extended-release formulations, reflecting the company’s commitment to addressing unmet medical needs.
Bookmark this page for direct access to ANIP’s latest corporate announcements, partnership details, and therapeutic pipeline progress. Stay informed about developments in cGMP-compliant production and market expansions through verified, up-to-date reporting.
ANI Pharmaceuticals reported Q2 2024 net revenues of $138 million, a YoY growth of 18.4%. Rare Disease revenues hit a record $49.2 million, up 102.4% YoY. Adjusted non-GAAP EBITDA was $33.2 million, and adjusted non-GAAP EPS was $1.02. However, they posted a net loss of $(2.7) million and a GAAP loss per share of $(0.14). The company plans to close the acquisition of Alimera Sciences in Q3 2024.
ANI raised its 2024 guidance, projecting net revenues between $540 million and $560 million, adjusted non-GAAP EBITDA of $140 million to $150 million, and adjusted non-GAAP EPS of $4.38 to $4.82. This guidance includes revenue from Cortrophin Gel, expected to be $185 million to $195 million, a YoY growth of 65% to 74%.
ANI Pharmaceuticals (NASDAQ: ANIP) has announced its plans to release second quarter 2024 financial results on Tuesday, August 6, 2024, before the market opens. The company will host a conference call at 8:30 a.m. ET on the same day to discuss the results. Nikhil Lalwani, President and CEO, and Stephen P. Carey, SVP of Finance and CFO, will lead the call.
Investors and interested parties can access the call toll-free at 800-245-3047 using the Conference ID 4619279. A live webcast and replay will be available on the company's website under the 'Investors' section. For those unable to attend, a replay will be accessible for two weeks by dialing 800-753-5212 with the same access code.
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.
