ANI PHARMACEUTICALS INC

ANI Pharmaceuticals announced positive topline data from its Phase 4 SYNCHRONICITY clinical trial for Fluocinolone Acetonide Intravitreal Implant (ILUVIEN) in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The trial met both co-primary endpoints, showing statistically significant improvements in best corrected visual acuity (BCVA) and central subfield thickness (CST) at 6 months. Adverse events were consistent with prior trials, with ocular hypertension and cataract being the most common. The company plans to present detailed results at upcoming medical conferences in Q4 2026.

ANI Pharmaceuticals, Inc. held its 2026 Annual Meeting of Stockholders where several key proposals were approved. Stockholders elected all seven director nominees and ratified the appointment of Ernst & Young LLP as the independent auditor for the fiscal year ending December 31, 2026. Additionally, the Company's Amended and Restated 2022 Stock Incentive Plan was approved, along with the compensation of named executive officers on an advisory basis. Stockholders also voted for future advisory votes on executive compensation to be held annually.

ANI Pharmaceuticals reported strong Q1 2026 results, with total net revenues increasing 20% to $237.5 million and adjusted non-GAAP EBITDA rising 24% to $63.0 million. The company also raised its full-year 2026 financial guidance, projecting total net revenues of $1.08 billion to $1.14 billion and adjusted non-GAAP EBITDA of $285 million to $300 million. Additionally, the Board authorized a new $100 million share repurchase program and the company recognized a $15 million upfront license fee from an out-licensing deal with Harmony Biosciences.

ANI Pharmaceuticals reported a significant increase in its first-quarter 2026 financial results, with net income rising by 88% and total net revenues growing by over 20% year-over-year. The company saw strong performance in its Rare Disease and Brands segment, particularly from Cortrophin Gel, and recognized an upfront license fee from a new IP agreement. Operating cash flow also improved substantially.

ANI Pharmaceuticals reported strong first-quarter 2026 financial results, with net revenues increasing 20.5% year-over-year to $237.5 million and adjusted non-GAAP EBITDA growing 24.1% to $63.0 million. The company saw significant growth in its Rare Disease segment, particularly Cortrophin Gel, and continued momentum in its Generics business. Based on this performance, ANI Pharmaceuticals raised its full-year 2026 financial guidance for total net revenue and adjusted non-GAAP EBITDA. Additionally, the Board of Directors authorized a new $100 million share repurchase program.

ANI Pharmaceuticals reported strong first-quarter 2026 financial results, with net revenues increasing 20.5% year-over-year to $237.5 million and adjusted non-GAAP EBITDA rising 24.1% to $63.0 million. The company also raised its full-year 2026 financial guidance for total net revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS, reflecting confidence in continued growth. Additionally, the Board of Directors authorized a new $100 million share repurchase program.

ANI Pharmaceuticals, Inc. announced it will release its first quarter 2026 financial results on Friday, May 8, 2026, prior to the market open. The company will host a webcast and conference call to discuss these results, featuring President and CEO Nikhil Lalwani, CFO Stephen P. Carey, and Head of Rare Disease Chris Mutz. Investors can access details for the event on the company's website.

ANI Pharmaceuticals, Inc. announced the launch of Carbamazepine Extended-Release Capsules in 100 mg, 200 mg, and 300 mg strengths. This product is the generic version of Carbatrol® and is considered a limited competition product, aiming to improve patient access to essential medicines. The U.S. annual sales for Carbamazepine Extended-Release Capsules are approximately $65 million, based on February 2026 IQVIA data.

ANI Pharmaceuticals, Inc. (ANIP) announced a change in its independent registered public accounting firm, effective April 1, 2026. The company dismissed EisnerAmper LLP and simultaneously appointed Ernst & Young LLP (EY) to serve in this capacity. This transition appears to be a routine change, as the company explicitly stated there were no disagreements or reportable events with EisnerAmper concerning accounting principles, financial disclosures, or auditing scope for the fiscal years ended December 31, 2025, and 2024. The Audit and Finance Committee of the Board of Directors approved both the dismissal and the appointment.