ANI Pharmaceuticals (ANIP) Conference Call Summary Company Overview - **Company**: ANI Pharmaceuticals - **Product Discussed**: ILUVIEN - **Date of Call**: July 23, 2025 Key Industry and Company Insights Clinical Trial Results - The New Day clinical trial evaluated ILUVIEN as a baseline therapy for early diabetic macular edema (DME) patients, comparing it to aflibercept, an anti-VEGF therapy [9][22] - The trial is one of the largest studies comparing corticosteroid therapy to anti-VEGF therapy in DME treatment [9] - ILUVIEN is a long-acting intravitreal implant releasing corticosteroid fluocinolone acetonide for up to 36 months, indicated for DME and chronic non-infectious uveitis [14] Financial Performance - Preliminary unaudited financial results for Q2 2025 show combined net revenues for ILUVIEN and YUTIQ at $22.3 million, a 38.5% increase from Q1 2025's $16.1 million [12][50] Treatment Insights - ILUVIEN is positioned as a significant option for DME patients, particularly those not well served by anti-VEGF therapies [49] - The trial results suggest ILUVIEN may reduce treatment burden and support earlier usage in DME management [49] - The study identified a target market of over 50,000 DME patients with suboptimal responses to anti-VEGF treatments, with ILUVIEN currently being used in less than 5,000 patients annually [61][91] Safety and Efficacy - The New Day trial indicated that while ILUVIEN required fewer supplemental injections compared to aflibercept, the difference did not reach statistical significance [35] - The mean time to supplemental therapy was significantly longer for ILUVIEN (185 days) compared to aflibercept (132 days) [36] - Safety profile showed a higher incidence of cataracts and intraocular pressure (IOP) elevation in the ILUVIEN group, which is expected with steroid treatments [44][45] Market Dynamics - The competitive landscape for DME treatments includes various anti-VEGF options, but ILUVIEN addresses the inflammatory aspects of DME, which are not fully managed by anti-VEGF therapies [76] - The New Day trial results are expected to influence physician adoption of ILUVIEN for earlier treatment in DME patients [85] Additional Important Points - The trial's design included a steroid challenge to assess safety and tolerability before treatment [22] - The study's findings are being presented at various national and international conferences to increase awareness and understanding of ILUVIEN's benefits [90] - The company plans to continue analyzing the New Day results and share further data to support its marketing strategy [49][50] This summary encapsulates the critical insights from the ANI Pharmaceuticals conference call, focusing on the New Day clinical trial results, financial performance, treatment implications, and market dynamics surrounding ILUVIEN.

Core Insights - ANI Pharmaceuticals, Inc. announced results from the NEW DAY clinical trial evaluating ILUVIEN for diabetic macular edema (DME) [1][2] - The trial compared the mean number of supplemental aflibercept injections needed in patients treated with ILUVIEN versus those treated with aflibercept [2][3] - The primary endpoint was not met, but secondary endpoints showed a significant reduction in time to first supplemental injection for the ILUVIEN arm [2][4] Study Design and Results - The NEW DAY trial was a multicenter, randomized, active-controlled study involving 306 eyes of treatment-naïve DME patients [8] - Patients were randomized to receive either a single ILUVIEN injection or five monthly aflibercept injections, followed by supplemental injections as needed [2][8] - In the intent-to-treat population, the ILUVIEN arm had a mean of 2.4 supplemental injections compared to 2.5 in the aflibercept arm, which was not statistically significant (p=0.756) [2] - In a post-hoc analysis, the ILUVIEN arm showed a statistically significant reduction in supplemental injections (1.8 vs. 2.5, p=0.029) [3] Secondary Endpoints - The mean time from the last treatment injection to the first supplemental injection was significantly longer in the ILUVIEN arm (185.4 days) compared to the aflibercept arm (132.8 days, p<0.001) [2] - Visual acuity changes showed non-inferiority between the two arms, with a mean change of 1.8 letters in the ILUVIEN arm versus 5.5 letters in the aflibercept arm (p=0.080) [5] - Central subfield thickness changes were also similar, with ILUVIEN showing a mean change of -118.8 µm compared to -113.6 µm for aflibercept (p=0.709) [6] Safety Profile - ILUVIEN was well tolerated, with 41% of patients experiencing treatment-related adverse events, primarily cataracts and increased intraocular pressure [7] - Serious treatment-related adverse events were not reported in either arm [7] - The incidence of intraocular pressure increase was higher in the ILUVIEN arm (16%) compared to the aflibercept arm (3%) [7] Implications for Treatment - The results suggest that ILUVIEN may reduce the treatment burden for patients with DME, potentially supporting its earlier use in clinical practice [4][7] - The study highlights the multifactorial nature of DME and the need for effective treatment options [4]

Core Viewpoint - Innovent Biologics has initiated the Phase 2 clinical study of efdamrofusp alfa for treating diabetic macular edema (DME), a significant health issue affecting millions of diabetic patients in China [1][2][3]. Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focusing on developing high-quality medicines for various diseases, including oncology, cardiovascular, metabolic, autoimmune, and ophthalmology [10]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, indicating a robust pipeline for future growth [10]. Clinical Study Details - The Phase 2 study (NCT06908876) will enroll 150 participants, randomized into three groups to evaluate the efficacy and safety of efdamrofusp alfa compared to Faricimab [2]. - The primary endpoint of the study is the change in best corrected visual acuity (BCVA) at week 16 [2]. Disease Context - DME is a leading cause of vision impairment among the diabetic population in China, with an estimated 4 to 5 million patients affected [3]. - The condition is primarily driven by microvascular damage and inflammation, leading to retinal edema and visual impairment [4][8]. Treatment Landscape - Current treatments for DME include anti-VEGF agents and glucocorticoids, but they require frequent injections, which can lead to poor patient compliance [4]. - Efdamrofusp alfa is a first-in-class bispecific fusion protein that targets both VEGF and complement pathways, potentially offering improved efficacy and extended dosing intervals [5][9]. Expert Insights - The Principal Investigator of the study highlighted the significant unmet medical needs in DME treatment, emphasizing the potential of efdamrofusp alfa to address these challenges [6]. - The Senior Vice President of Clinical Development noted that this study is the first to compare two dual-target agents in DME, which could pave the way for future Phase 3 trials [6].