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]

Core Viewpoint - ANI Pharmaceuticals, Inc. has initiated a Phase 4 clinical trial to evaluate the safety and efficacy of two dose levels of Purified Cortrophin Gel for treating acute gout flares, marking a significant step in the company's commitment to building scientific evidence for this therapy [1][3]. Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics, particularly in rare diseases, ophthalmology, rheumatology, nephrology, neurology, and pulmonology [11]. Clinical Trial Details - The Phase 4 trial will compare two dose levels (40 USP units and 80 USP units) of Cortrophin Gel in a randomized, double-blind study involving up to 160 patients, aiming to enroll 70 evaluable patients per dose group [4][5]. - The primary endpoint is the change in gout pain intensity from baseline at day 3 post-administration, measured by Visual Analog Scale (VAS) [5]. Expert Involvement - Dr. Hyon Choi, a leading physician investigator with extensive experience in gout research, will conduct the trial, emphasizing the need for effective treatments for patients who do not respond adequately to conventional therapies [2][3]. Product Background - Cortrophin Gel is the only ACTH therapy approved by the FDA for acute gout flares and is indicated for short-term administration as an adjunctive therapy during acute episodes [1][7]. - The product has seen steady growth since the launch of a 1-mL vial in October 2023, aimed at increasing access for in-office treatment [3].

Financial Data and Key Metrics Changes - The company provided guidance for 2025 revenues between $768 million and $793 million, representing a year-over-year growth of approximately 25% to 29% [4][5] - Adjusted non-GAAP EBITDA guidance for 2025 is between $195 million and $205 million [4] - Q1 2025 revenues reached a record $197 million with adjusted non-GAAP EBITDA of $51 million [6] Business Line Data and Key Metrics Changes - The rare disease segment is the primary growth driver, with Cortrophin Gel expected to generate $265 million to $274 million in 2025, reflecting a year-over-year growth of 384% to 38% [8][9] - Generic revenues reached a record high of $98.7 million in Q1 2025, driven by successful new product launches [8] - The generics business is expected to sustain high single-digit to low double-digit growth, with a mid double-digit growth forecast for 2025 [37] Market Data and Key Metrics Changes - The ACTH market, which includes Cortrophin Gel, is projected to grow to $792 million in 2025, with a 16% growth rate [16] - The addressable market for Cortrophin Gel is significantly larger than the current patient population, indicating substantial growth potential [19][20] Company Strategy and Development Direction - The company aims to reinvest cash flows from generics and established brands into the rare disease business, which is expected to account for approximately half of 2025 revenues [4][36] - The acquisition of Alimera is intended to expand the rare disease business and align with the company's M&A strategy [24][32] - The company is focusing on expanding the adoption of Cortrophin Gel in targeted specialties and addressing sales factors impacting ILUVIEN and YUTIQ [38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning, with over 90% of revenues coming from U.S.-manufactured products and minimal reliance on China [5] - The management highlighted the strong growth momentum in the rare disease segment, particularly for Cortrophin Gel, and the ongoing investment in R&D to support this growth [20][23] Other Important Information - The company has a healthy balance sheet with $150 million in cash and a net leverage of 2.7 turns [4][38] - The generics business launched 17 products in 2024, including two competitive generic therapy products with exclusivity [33] Q&A Session Summary Question: What is the growth outlook for Cortrophin Gel? - Management indicated that Cortrophin Gel is on a strong multiyear growth trajectory, with significant headroom for expansion in its addressable market [19][20] Question: How is the company addressing the sales impact on ILUVIEN and YUTIQ? - The company is focusing on capturing larger opportunities in diabetic macular edema and chronic noninfectious uveitis, while also expanding the sales team to drive growth [38] Question: What are the priorities for 2025? - The company outlined four key priorities: expanding Cortrophin Gel adoption, addressing sales factors for ILUVIEN and YUTIQ, sustaining generics momentum, and expanding the rare disease business through M&A [38]

Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics [3] - The company aims to deliver sustainable growth through its Rare Disease business, Generics business, and Brands business [3] Upcoming Event - ANI Pharmaceuticals will present at the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, at 1:30 PM ET [1] - A live and archived webcast of the presentation will be available on the company's website for 90 days [2]