ANI Pharmaceuticals(ANIP) - 2025 Q2 - Quarterly Results

Main Announcement & Trial Results Overview of the NEW DAY Clinical Trial Results The NEW DAY trial for ILUVIEN® in DME did not meet its primary endpoint but succeeded on a key secondary endpoint - The NEW DAY trial evaluated ILUVIEN® against aflibercept for treating DME in treatment-naïve or almost naïve patients[1][2] - 33% of patients in the ILUVIEN arm did not require a supplemental injection, a non-statistically significant difference[3] Primary and Key Secondary Endpoint Results (ITT Population) | Endpoint | ILUVIEN Arm (n=154) | Aflibercept Arm (n=152) | P-value | Outcome | | :--- | :--- | :--- | :--- | :--- | | Primary: Mean Supplemental Injections | 2.4 | 2.5 | p=0.756 | Not Met | | Secondary: Mean Time to First Supplemental Injection | 185.4 days | 132.8 days | p<0.001 | Met | Detailed Trial Results and Analysis A post-hoc analysis showed a significant reduction in injections for ILUVIEN, which also demonstrated non-inferiority on secondary endpoints - A post-hoc analysis of patients without major protocol deviations showed a statistically significant difference in the mean number of supplemental injections: 1.8 for the ILUVIEN arm versus 2.5 for the aflibercept arm (p=0.029)[4] - Secondary endpoints for best corrected visual acuity (BCVA) and central subfield thickness (CST) demonstrated non-inferiority between the two treatment arms in the ITT population[6] Total Injections in Post-Hoc Patient Population | Arm | Initial Injections | Mean Supplemental Injections | Total Injections | | :--- | :--- | :--- | :--- | | ILUVIEN (n=128) | 1 | 1.8 | 2.8 | | Aflibercept (n=134) | 5 | 2.5 | 7.5 | Management Commentary Management and clinical experts highlighted the trial's positive outcomes, suggesting ILUVIEN's potential for earlier clinical use - Dr. Michael A. Singer noted that the study provides clinically meaningful data on ILUVIEN's potential to reduce treatment burden[5] - CEO Nikhil Lalwani stated that the data could support earlier usage of ILUVIEN to reduce treatment burden in DME[7] Safety Profile ILUVIEN was well-tolerated with a consistent safety profile, though it showed higher rates of cataract and increased intraocular pressure - The most common treatment-related adverse events in the ILUVIEN arm were cataract/subcapsular cataract (n=50) and increased IOP (n=24)[8] - No serious treatment-related treatment-emergent adverse events were observed in either arm of the study[8] Key Treatment-Emergent Adverse Events (ITT Population) | Adverse Event | ILUVIEN Arm | Aflibercept Arm | | :--- | :--- | :--- | | Any Treatment-Related TEAE | 41% | 3% | | Increase in Intraocular Pressure (IOP) | 16% | 3% | | IOP ≥25 mmHg | 11% | 3% | | Required IOP-lowering Intervention | 4.5% | 1.3% | Trial and Product Information About The NEW DAY Clinical Trial The trial compared a single ILUVIEN implant against five monthly aflibercept injections in 306 eyes with DME across the U.S - The study was a prospective, multicenter, masked, randomized, active-controlled trial that enrolled 306 eyes of treatment-naïve, or almost naïve, DME patients[9] - Patients were randomized to either a single ILUVIEN implant or five initial monthly injections of aflibercept, followed by a 13-month maintenance period[9] About Diabetic Macular Edema (DME) DME is a complication of diabetes where leaking blood vessels cause macular swelling, potentially leading to vision loss - DME occurs when blood vessels leak into the macula, causing swelling that can lead to blurry vision and vision loss[10] ILUVIEN Important Safety Information This section details ILUVIEN's indication, contraindications, warnings, precautions, and common adverse reactions observed in trials Indication and Contraindications - ILUVIEN is indicated for DME in patients previously treated with corticosteroids without a significant rise in intraocular pressure[11] - The drug is contraindicated in patients with active ocular infections, advanced glaucoma, or known hypersensitivity[14] Warnings and Precautions - Intravitreal injections with ILUVIEN are associated with risks such as endophthalmitis, eye inflammation, and increased intraocular pressure (IOP)[14] - Prolonged corticosteroid use may lead to glaucoma and posterior subcapsular cataract formation[14] - There is a risk of the implant migrating into the anterior chamber if the posterior capsule of the lens is absent or torn[17] Adverse Reactions - In clinical trials, 38% of ILUVIEN patients required IOP-lowering medications versus 14% of sham patients[15] Most Common Ocular Adverse Reactions (≥5%) | Adverse Reaction | Incidence | | :--- | :--- | | Cataract | 82% | | Myodesopsia (Floaters) | 21% | | Eye Pain | 15% | | Conjunctival Hemorrhage | 13% | | Posterior Capsule Opacification | 9% | | Eye Irritation | 8% | | Vitreous Detachment | 7% | Corporate Information and Events Conference Call Information ANI Pharmaceuticals hosted a conference call and webcast on July 23, 2025, to discuss the NEW DAY clinical trial results Conference Call Details | Item | Detail | | :--- | :--- | | Date | Wednesday, July 23, 2025 | | Time | 8:30 am ET | | Toll Free (U.S.) | 800-267-6316 | | Webcast | "Investors" section of ANI's website | About ANI Pharmaceuticals, Inc. ANI Pharmaceuticals is a diversified biopharmaceutical company operating across Rare Disease, Generics, and Brands segments - ANI Pharmaceuticals is a diversified biopharmaceutical company with a mission of "Serving Patients, Improving Lives"[21] - The company's business is structured into three segments: Rare Disease, Generics, and Brands[21] Forward-Looking Statements This press release contains forward-looking statements subject to significant risks that could cause actual results to differ materially - The press release contains forward-looking statements based on current expectations and assumptions, which are subject to various risks and uncertainties[22] - Key risk factors include product commercialization, acquisition integration, supplier reliance, and potential regulatory actions[23]