Group 1 - ANI Pharmaceuticals, Inc. will release its second quarter 2025 financial results on August 8, 2025, prior to market open [1] - A conference call will be hosted by key executives to discuss the financial results on August 8, 2025, at 8:30 a.m. ET [2] - The company is focused on sustainable growth through its Rare Disease business, Generics business, and Brands business [3] Group 2 - The Rare Disease business markets novel products in ophthalmology, rheumatology, nephrology, neurology, and pulmonology [3] - ANI Pharmaceuticals is committed to developing, manufacturing, and commercializing innovative and high-quality therapeutics [3] - The company emphasizes its mission of "Serving Patients, Improving Lives" [3]

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.

[Main Announcement & Trial Results](index=1&type=section&id=Main%20Announcement%20%26%20Trial%20Results) [Overview of the NEW DAY Clinical Trial Results](index=1&type=section&id=Overview%20of%20the%20NEW%20DAY%20Clinical%20Trial%20Results) 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](index=1&type=chunk)[2](index=2&type=chunk) - **33% of patients** in the ILUVIEN arm did not require a supplemental injection, a non-statistically significant difference[3](index=3&type=chunk) 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](index=2&type=section&id=Detailed%20Trial%20Results%20and%20Analysis) 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](index=4&type=chunk) - 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](index=6&type=chunk) 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](index=2&type=section&id=Management%20Commentary) 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](index=5&type=chunk) - CEO Nikhil Lalwani stated that the data could support **earlier usage of ILUVIEN** to reduce treatment burden in DME[7](index=7&type=chunk) [Safety Profile](index=3&type=section&id=Safety%20Profile) 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](index=8&type=chunk) - **No serious treatment-related** treatment-emergent adverse events were observed in either arm of the study[8](index=8&type=chunk) 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](index=3&type=section&id=Trial%20and%20Product%20Information) [About The NEW DAY Clinical Trial](index=3&type=section&id=About%20The%20NEW%20DAY%20Clinical%20Trial) 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](index=9&type=chunk) - Patients were randomized to either a single ILUVIEN implant or five initial monthly injections of aflibercept, followed by a 13-month maintenance period[9](index=9&type=chunk) [About Diabetic Macular Edema (DME)](index=4&type=section&id=About%20Diabetic%20Macular%20Edema%20(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](index=10&type=chunk) [ILUVIEN Important Safety Information](index=4&type=section&id=ILUVIEN%20Important%20Safety%20Information) This section details ILUVIEN's indication, contraindications, warnings, precautions, and common adverse reactions observed in trials [Indication and Contraindications](index=4&type=section&id=Indication%20and%20Contraindications) - ILUVIEN is indicated for DME in patients previously treated with corticosteroids without a significant rise in intraocular pressure[11](index=11&type=chunk) - The drug is contraindicated in patients with active ocular infections, advanced glaucoma, or known hypersensitivity[14](index=14&type=chunk) [Warnings and Precautions](index=4&type=section&id=Warnings%20and%20Precautions) - Intravitreal injections with ILUVIEN are associated with risks such as endophthalmitis, eye inflammation, and increased intraocular pressure (IOP)[14](index=14&type=chunk) - Prolonged corticosteroid use may lead to **glaucoma** and **posterior subcapsular cataract formation**[14](index=14&type=chunk) - There is a risk of the implant migrating into the anterior chamber if the posterior capsule of the lens is absent or torn[17](index=17&type=chunk) [Adverse Reactions](index=5&type=section&id=Adverse%20Reactions) - In clinical trials, **38% of ILUVIEN patients** required IOP-lowering medications versus 14% of sham patients[15](index=15&type=chunk) 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](index=6&type=section&id=Corporate%20Information%20and%20Events) [Conference Call Information](index=6&type=section&id=Conference%20Call%20Information) 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.](index=6&type=section&id=About%20ANI%20Pharmaceuticals%2C%20Inc.) 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](index=21&type=chunk) - The company's business is structured into three segments: **Rare Disease, Generics, and Brands**[21](index=21&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) 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](index=22&type=chunk) - Key risk factors include product commercialization, acquisition integration, supplier reliance, and potential regulatory actions[23](index=23&type=chunk)

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]

Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics [2] - The company aims to deliver sustainable growth through its Rare Disease business, Generics business, and Brands business [2] Recent Developments - Nikhil Lalwani, President and CEO of ANI Pharmaceuticals, will host 1x1 meetings at the Leerink Partners Therapeutics Forum: I&I and Metabolism on July 8, 2025, in Boston, MA [1]

Financial Performance and Guidance - ANI Pharmaceuticals projects net revenues of $768 million to $793 million for 2025, representing a year-over-year growth of 25% to 29%[10] - The company anticipates adjusted non-GAAP EBITDA of $195 million to $205 million in 2025[10] - Adjusted non-GAAP diluted EPS is expected to be between $627 and $662 in 2025[26] - Generics revenue in Q1 2025 reached $99 million, up 41% year-over-year and 26% quarter-over-quarter[69, 70] Rare Disease Business - Cortrophin Gel net revenue is projected to be $265 million to $274 million in 2025, a 34% to 38% increase from 2024[26] - ILUVIEN and YUTIQ net revenue is expected to be $97 million to $103 million in 2025[26] - Acute gouty arthritis flares now account for approximately 18% of Cortrophin Gel usage[23] Strategic Focus and Operations - Approximately 95% of total company revenues are from products sold in the U S [10] - Over 90% of total company revenues are sourced from finished goods manufactured in the U S [10] - The company has $150 million in cash as of March 31, 2025[10]

Core Insights - ANI Pharmaceuticals, Inc. presented new preclinical data on Purified Cortrophin Gel at the EULAR 2025 Congress, demonstrating its efficacy in a murine model of collagen-induced arthritis [1][5] Group 1: Research Findings - In a preclinical model, repository corticotrophin injection (RCI) significantly reduced joint swelling and inflammatory cytokine response in mice without causing additional bone turnover, with the most pronounced effect observed at a dosage of 400 U/kg [2] - RCI treatment showed a dose-dependent effect on attenuating clinical scores and joint swelling compared to vehicle control, indicating its potential as a therapeutic option [2] Group 2: Research Leadership - The research was led by prominent figures in the field, including Maripat Corr, MD, and Nancy Lane, MD, from the University of California [3] Group 3: Company Commitment - ANI Pharmaceuticals emphasized its commitment to scientific and clinical research, collaborating with leading scientists to enhance understanding of its products and improve patient outcomes [4]

ANI Pharmaceuticals (ANIP) Conference Call Summary Company Overview - ANI Pharmaceuticals operates three business units: Rare Disease, Genetics, and Brands [2][3] - Rare Disease is the primary growth driver with key products including Cortrophin Gel, Iluvien, and YUTIQ [3] Financial Guidance and Performance - 2025 revenue guidance is set between $768 million to $793 million, representing a growth of 25% to 29% [4] - Adjusted non-GAAP EBITDA guidance is between $195 million to $205 million [4] - The company reported $197 million in total revenues for Q1 2025, with $94.1 million from Rare Disease [5] - Cortrophin Gel generated approximately $53 million in revenues during Q1 2025 [6] Rare Disease Business Insights - Cortrophin Gel is expected to generate $265 million to $274 million in revenue for 2025, reflecting a growth of 34% to 38% [10] - The Rare Disease segment is projected to reach $362 million to $377 million in revenue, showing a CAGR of nearly 106% over the last four years [11] - Cortrophin Gel is approved for 22 indications, focusing on six key areas including rheumatoid arthritis and acute gouty arthritis flares [12][13] - The ACTH market, where Cortrophin operates, is expected to grow from $684 million in 2024 to $792 million in 2025 [15] Generics Business Performance - The generics segment achieved record revenues of $98.7 million in Q1 2025, up 41% year-on-year [32] - ANI launched 17 new products in 2024, including two with competitive genetic therapy designation [32] Strategic Initiatives - The company is expanding its sales force, adding 20 new representatives focused on rheumatology, nephrology, and neurology [40][43] - A long-term contract with CMO Sigfried has been extended to enhance supply chain security for ILUVIEN and YUTIQ [24] - The Alimera acquisition has provided ANI with an international footprint, with 30% of ILUVIEN and YUTIQ revenues generated outside the U.S. [28][29] Market Dynamics and Challenges - Q1 revenues for ILUVIEN and YUTIQ were impacted by Medicare patient support funding issues and sales force turnover [7] - The company is addressing these challenges by tailoring its commercial approach and ensuring appropriate patient access to therapies [50][51] Conclusion - ANI Pharmaceuticals is well-positioned for growth in 2025, driven by its Rare Disease business and a robust generics segment [34] - The company maintains a strong balance sheet with $150 million in cash and a net leverage of 2.7 turns [4]

Financial Performance - Record quarterly net revenues of $197.1 million, representing year-over-year growth of 43.4%[4] - Rare Disease net revenues totaled $69.0 million, with Cortrophin Gel generating $52.9 million, an increase of 43.1% year-over-year[4][14] - Generics net revenues reached $98.7 million, reflecting a 40.5% year-over-year increase driven by new product launches[4][11] - Adjusted non-GAAP EBITDA for the first quarter was $50.7 million, an increase of 34.9% from the previous year[19] - Net revenues for Q1 2025 increased to $197,122,000, up from $137,430,000 in Q1 2024, representing a growth of approximately 43.5%[47] - Operating income for Q1 2025 was $26,194,000, compared to $20,312,000 in Q1 2024, indicating an increase of about 29.1%[47] - Adjusted non-GAAP EBITDA for the three months ended March 31, 2025, was $50,749 thousand, an increase of 34.8% from $37,633 thousand in the prior year[51] - Adjusted non-GAAP net income available to common shareholders for Q1 2025 was $34,144 thousand, up 45.5% from $23,466 thousand in Q1 2024[54] - Adjusted diluted earnings per share for the three months ended March 31, 2025, was $1.70, compared to $1.21 for the same period in 2024, reflecting an increase of 40.5%[54] Guidance and Future Projections - The company raised its 2025 guidance to expected net revenues of $768.0 million to $793.0 million, and adjusted non-GAAP diluted EPS of $6.27 to $6.62[4][21] - Cortrophin Gel is expected to generate net revenues of $265.0 million to $274.0 million in 2025, representing year-over-year growth of 33.8% to 38.3%[4][21] - Forward-looking guidance for 2025 adjusted diluted earnings per share is not provided due to insufficient information for accurate estimates[33] Expenses and Costs - The company experienced a 59.4% increase in selling, general, and administrative expenses to $76.5 million due to the acquisition of Alimera Sciences[17] - Total operating expenses for Q1 2025 were $170,928,000, compared to $117,118,000 in Q1 2024, an increase of approximately 46%[47] - Selling, general, and administrative expenses rose to $76,528,000 in Q1 2025 from $48,021,000 in Q1 2024, marking an increase of approximately 59.3%[47] - Research and development expenses for Q1 2025 were $10,564,000, slightly up from $10,511,000 in Q1 2024, showing a marginal increase of about 0.5%[47] - The company reported a significant increase in research and development expenses, totaling $76,528 thousand for Q1 2025, compared to $48,021 thousand in Q1 2024, reflecting a growth of 59.3%[51] Income and Earnings - The company reported diluted GAAP income per share of $0.69 and record adjusted non-GAAP diluted earnings per share of $1.70 for the first quarter[18] - Basic income per share for Q1 2025 was $0.70, down from $0.84 in Q1 2024, a decline of approximately 16.7%[47] - Diluted income per share for Q1 2025 was $0.69, compared to $0.82 in Q1 2024, reflecting a decrease of about 15.9%[47] - Net income for the three months ended March 31, 2025, was $15,681 thousand, a decrease of 13.4% compared to $18,207 thousand for the same period in 2024[51] - Adjusted non-GAAP net income for Q1 2025 was $15,681,000, compared to $18,207,000 in Q1 2024, reflecting a decrease of approximately 8.4%[47] Assets and Liabilities - Total current assets increased to $536,290 thousand as of March 31, 2025, up from $527,684 thousand on December 31, 2024, representing a growth of 1.15%[49] - Total liabilities decreased to $848,958 thousand as of March 31, 2025, down from $855,167 thousand on December 31, 2024, a reduction of 0.7%[49] - Cash and cash equivalents increased to $149,802 thousand as of March 31, 2025, compared to $144,861 thousand on December 31, 2024, marking a rise of 3.3%[49] - Current liabilities rose to $201,815 thousand as of March 31, 2025, up from $193,680 thousand at the end of 2024, indicating an increase of 4.9%[49] - The company’s total assets reached $1,292,428 thousand as of March 31, 2025, an increase from $1,283,697 thousand on December 31, 2024, representing a growth of 0.6%[49] Market and Product Insights - Approximately 40% of Cortrophin Gel prescribers were new to the ACTH category, indicating strong market penetration[6] - The company plans to market ILUVIEN under an expanded label that includes chronic non-infectious uveitis indications[9]

Core Points - ANI Pharmaceuticals, Inc. will present at the 2025 Jefferies Global Healthcare Conference on June 4, 2025, at 2:35pm ET [1] - The live and archived webcast of the presentation will be available on the company's website for 60 days [2] - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing and commercializing innovative therapeutics, with a commitment to sustainable growth through its Rare Disease, Generics, and Brands businesses [3]