Core Insights - ANI Pharmaceuticals reported $211.37 million in revenue for Q2 2025, a 53.1% year-over-year increase, with an EPS of $1.80 compared to $1.02 a year ago, exceeding Zacks Consensus Estimates [1] - The company achieved a revenue surprise of +12.22% and an EPS surprise of +30.43% compared to analyst expectations [1] Revenue Breakdown - Net Revenues from Rare Disease and Brands - Cortrophin Gel: $81.65 million, surpassing the estimated $65.23 million [4] - Net Revenues from Rare Disease and Brands - ILUVIEN and YUTIQ: $22.32 million, slightly above the $21.74 million estimate [4] - Net Revenues from Generic pharmaceutical products: $90.3 million, exceeding the $85.32 million estimate [4] - Total Net Revenues from Rare Disease: $103.96 million, compared to the estimated $86.96 million [4] - Total Net Revenues from Generics and Other: $94.21 million, slightly below the $96.49 million estimate [4] - Net Revenues from Royalties and other pharmaceutical services: $3.92 million, significantly below the estimated $10.46 million [4] - Total Net Revenues from Rare Disease and Brands: $117.16 million, far exceeding the estimated $94.3 million, representing a year-over-year change of +138.2% [4] Stock Performance - ANI's shares have returned +25.4% over the past month, outperforming the Zacks S&P 500 composite's +2.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market [3]

Financial Data and Key Metrics Changes - The company reported total net revenues of $211.4 million for Q2 2025, representing a year-over-year growth of 53% on an as-reported basis and 37% on an organic basis [9][31] - Adjusted non-GAAP EBITDA was $54.1 million, compared to $33.2 million in the prior year period, reflecting strong operational performance [35] - Adjusted non-GAAP EPS was $1.80 for the second quarter, up from $1.02 in the prior year period [34] Business Line Data and Key Metrics Changes - Revenues from the rare disease segment were $104 million, up 111% from the prior year, driven by strong demand for Cortrophin Gel [31][32] - Cortrophin Gel revenues reached $81.6 million, a 66% increase year-over-year, with new patient starts and cases initiated at record highs [9][32] - The retina portfolio, including ILUVIEN and YUTIQ, generated revenues of $22.3 million, consistent with expectations despite ongoing market access challenges [13][32] - The generics business reported revenues of $90.3 million, a 22% increase over the prior year, supported by new product launches [17][32] Market Data and Key Metrics Changes - The ACTH market grew 27% to $684 million in 2024 and is expected to grow 36% to $933 million in 2025, indicating a robust market opportunity [11] - The current number of patients on ACTH therapy is significantly below historical levels, suggesting substantial room for expansion [11][12] Company Strategy and Development Direction - The company is raising its 2025 guidance for total net revenues to between $818 million and $843 million, reflecting strong momentum across both rare disease and generics business units [8][36] - The focus remains on expanding the Cortrophin Gel franchise and addressing market access challenges in the retina segment [12][17] - The company is committed to maintaining a strong presence in the U.S. pharmaceutical industry, with over 90% of revenues coming from domestically manufactured products [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining robust multiyear growth for Cortrophin Gel, driven by increased demand and a growing prescriber base [12][60] - The company anticipates continued challenges in the retina market due to Medicare access issues but remains optimistic about future revenue synergies [17][29] - Management highlighted the importance of ongoing investments in evidence generation and new product presentations to support long-term growth [43][60] Other Important Information - The company ended Q2 with $217.8 million in unrestricted cash, up from $149.8 million at the end of Q1 [35] - The gross margin for Q2 was 64.9%, an increase of over six points from the prior year, driven by a favorable mix towards rare disease products [34][35] Q&A Session Summary Question: Was there anything unusual in Cortrophin's performance? - Management confirmed that the performance was driven by underlying demand, with new patient starts more than doubling in Q2 2025 compared to Q2 2024 [42] Question: What are the priorities for capital use? - The company aims to build cash reserves for reinvestment into the business and potential M&A, with debt paydowns considered in the future [51] Question: How is the payer landscape expected to evolve? - Management indicated that they will continue to engage with payers as they bring Cortrophin therapy to appropriate patients, but specifics were not disclosed [75] Question: What is driving the growth in the ACTH class? - Multiple factors contribute to growth, including increased prescriber adoption, new indications, and the launch of easier-to-use dosage forms [60] Question: How is the prefilled syringe performing? - Seventy percent of new patient starts were with the prefilled syringe, indicating strong adoption across various indications [62] Question: What impact did the New Day trial results have on ILUVIEN? - While the feedback on the New Day study was positive, the expected benefits will be more long-term rather than immediately reflected in guidance [71]

Company Performance - ANI Pharmaceuticals reported quarterly earnings of $1.8 per share, exceeding the Zacks Consensus Estimate of $1.38 per share, and up from $1.02 per share a year ago, representing an earnings surprise of +30.43% [1] - The company posted revenues of $211.37 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 12.22%, compared to year-ago revenues of $138.04 million [2] - Over the last four quarters, ANI has consistently surpassed consensus EPS and revenue estimates [2] Stock Movement and Outlook - ANI shares have increased approximately 24.8% since the beginning of the year, significantly outperforming the S&P 500's gain of 7.8% [3] - The sustainability of the stock's price movement will depend on management's commentary during the earnings call and future earnings expectations [3][4] - The current consensus EPS estimate for the upcoming quarter is $1.53 on revenues of $193.41 million, and for the current fiscal year, it is $6.55 on revenues of $789.84 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which ANI belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, indicating potential challenges ahead [8] - The performance of ANI's stock may be influenced by the overall outlook for the industry, as research shows that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]

PART I — FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Unaudited H1 2025 financials show significant growth in assets, revenues, and net income, driven by the Alimera acquisition and new capital structure Condensed Consolidated Balance Sheet Highlights (as of June 30, 2025 vs. Dec 31, 2024) | Metric | June 30, 2025 ($ thousands) | Dec 31, 2024 ($ thousands) | Change | | :--- | :--- | :--- | :--- | | **Assets** | | | | | Cash and cash equivalents | 217,797 | 144,861 | ▲ $72,936 | | Total Current Assets | 602,630 | 527,684 | ▲ $74,946 | | Intangible assets, net | 520,320 | 541,834 | ▼ $21,514 | | Total Assets | 1,343,001 | 1,283,697 | ▲ $59,304 | | **Liabilities & Equity** | | | | | Total Current Liabilities | 236,835 | 193,680 | ▲ $43,155 | | Non-current debt, net | 301,484 | 309,108 | ▼ $7,624 | | Non-current convertible notes, net | 306,862 | 305,812 | ▲ $1,050 | | Total Liabilities | 881,394 | 855,167 | ▲ $26,227 | | Total Stockholders' Equity | 436,757 | 403,680 | ▲ $33,077 | Q2 2025 vs Q2 2024 Statement of Operations | Metric | Q2 2025 ($ thousands) | Q2 2024 ($ thousands) | YoY Change | | :--- | :--- | :--- | :--- | | Net Revenues | 211,371 | 138,040 | ▲ 53.1% | | Operating income | 13,892 | 5,169 | ▲ 168.7% | | Net Income (Loss) | 8,549 | (2,287) | ▲ N/A | | Diluted EPS | $0.36 | $(0.14) | ▲ N/A | H1 2025 vs H1 2024 Statement of Operations | Metric | H1 2025 ($ thousands) | H1 2024 ($ thousands) | YoY Change | | :--- | :--- | :--- | :--- | | Net Revenues | 408,493 | 275,470 | ▲ 48.3% | | Operating income | 40,086 | 25,481 | ▲ 57.3% | | Net Income | 24,230 | 15,920 | ▲ 52.2% | | Diluted EPS | $1.05 | $0.70 | ▲ 50.0% | Cash Flow Summary for the Six Months Ended June 30 | Cash Flow Category | 2025 ($ thousands) | 2024 ($ thousands) | | :--- | :--- | :--- | | Net Cash Provided by Operating Activities | 110,803 | 35,683 | | Net Cash (Used in) Provided by Investing Activities | (26,755) | 4,484 | | Net Cash Used in Financing Activities | (11,653) | (21,178) | | **Net Change in Cash** | **72,939** | **18,989** | - The significant increase in cash from operations in H1 2025 was driven by higher net income (**$24.2M** vs **$15.9M** YoY) and favorable changes in working capital, including accrued royalties and government rebates[24](index=24&type=chunk) - Investing activities in H1 2025 primarily consisted of **$20.3 million** for the acquisition of product rights and intangible assets. In contrast, H1 2024 included **$13.5 million** in proceeds from the sale of a building[24](index=24&type=chunk) - On September 16, 2024, the company completed its acquisition of Alimera Sciences, Inc., adding two new products, ILUVIEN® and YUTIQ®, for treating chronic retinal diseases[26](index=26&type=chunk) - The company sold its Oakville, Ontario manufacturing site in March 2024 for approximately **$14.2 million**, resulting in a gain of **$5.3 million** in H1 2024[27](index=27&type=chunk)[68](index=68&type=chunk) - In August 2024, the company issued **$316.3 million** of 2.25% Convertible Senior Notes due 2029 and entered into a new credit agreement for a **$325.0 million** term loan to finance the Alimera acquisition and repay previous debt[73](index=73&type=chunk)[81](index=81&type=chunk) - The company reorganized its business into two reportable segments: 'Rare Disease and Brands' and 'Generics and Other' following the Alimera acquisition[199](index=199&type=chunk)[200](index=200&type=chunk) - A subsequent event note indicates the 'One Big Beautiful Bill Act' was signed into law on July 4, 2025, which includes significant tax law changes that the company is currently evaluating[205](index=205&type=chunk)[206](index=206&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=50&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes strong Q2/H1 2025 performance to strategic execution, driven by Rare Disease and Brands growth, Alimera acquisition, and new capital structure - The company's strategy focuses on building a sustainable biopharmaceutical company with key growth drivers in its Rare Disease and Brands segment and its Generics and Other segment[211](index=211&type=chunk) - The acquisition of Alimera in September 2024 is a cornerstone of the strategy, strengthening the Rare Disease business with the ILUVIEN and YUTIQ 'Retina Franchise' and expanding the company's footprint beyond the U.S[209](index=209&type=chunk)[213](index=213&type=chunk) - Recent developments include the FDA approval of an expanded label for ILUVIEN and a new prefilled syringe format for Cortrophin Gel, both aimed at enhancing market position[215](index=215&type=chunk)[216](index=216&type=chunk) - In March 2025, the company exercised a buy-out option for **$17.3 million** to eliminate future royalty payments to SWK Funding LLC on ILUVIEN and YUTIQ net revenues[221](index=221&type=chunk) Q2 2025 vs Q2 2024 Net Revenue Breakdown ($ thousands) | Segment/Product | Q2 2025 | Q2 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Cortrophin Gel | 81,647 | 49,193 | 32,454 | 66.0% | | ILUVIEN and YUTIQ | 22,316 | — | 22,316 | n/m | | **Rare Disease & Brands Total** | **117,158** | **59,220** | **57,938** | **97.8%** | | **Generics and Other Total** | **94,213** | **78,820** | **15,393** | **19.5%** | | **Total Net Revenues** | **211,371** | **138,040** | **73,331** | **53.1%** | H1 2025 vs H1 2024 Net Revenue Breakdown ($ thousands) | Segment/Product | H1 2025 | H1 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Cortrophin Gel | 134,497 | 86,130 | 48,367 | 56.2% | | ILUVIEN and YUTIQ | 38,425 | — | 38,425 | n/m | | **Rare Disease & Brands Total** | **211,240** | **121,836** | **89,404** | **73.4%** | | **Generics and Other Total** | **197,253** | **153,634** | **43,619** | **28.4%** | | **Total Net Revenues** | **408,493** | **275,470** | **133,023** | **48.3%** | - Q2 2025 Cost of Sales increased **29.3%** to **$74.6 million** due to higher sales volumes, but decreased as a percentage of revenue to **35.3%** from **41.8%** YoY, indicating improved product mix/margins[234](index=234&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk) - Q2 2025 operating expenses increased significantly: R&D rose **126.6%** to **$16.5 million**, and SG&A grew **54.8%** to **$81.8 million**, reflecting investments to support the expanded business post-Alimera acquisition[237](index=237&type=chunk)[242](index=242&type=chunk) - The company's capital structure was reshaped in 2024 with a new **$325.0 million** Term Loan A and the issuance of **$316.3 million** in 2.25% Convertible Senior Notes to fund the Alimera acquisition and refinance old debt[255](index=255&type=chunk)[261](index=261&type=chunk) - As of June 30, 2025, **$75.0 million** remains available for borrowing under the TLA Revolver[257](index=257&type=chunk)[272](index=272&type=chunk) - Net cash from operations for H1 2025 was **$110.8 million**, a significant increase from **$35.7 million** in H1 2024, driven by higher net income and working capital improvements[274](index=274&type=chunk) - Management believes that current financial resources are sufficient to meet working capital requirements and debt obligations for at least the next 12 months[272](index=272&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=64&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes in the company's exposure to market risks, including interest rate, equity, and foreign currency, since fiscal year 2024 end - There have been no material changes in the company's exposure to market risks since the end of the most recent fiscal year as reported in the 2024 Form 10-K[278](index=278&type=chunk) [Item 4. Controls and Procedures](index=65&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[280](index=280&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[281](index=281&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=65&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal proceedings, including commercial and patent litigation, with outcomes uncertain, as detailed in Note 15 - The company is involved in ongoing legal proceedings, which are detailed in Note 15 of the financial statements[282](index=282&type=chunk) - Key legal matters include commercial litigation against CG Oncology, where a jury returned a verdict of no damages for ANI, which ANI plans to challenge, and a false advertising lawsuit with Acella Pharmaceuticals[159](index=159&type=chunk)[161](index=161&type=chunk) - The company is also a defendant in patent litigation concerning its generic drug applications and in broader litigation related to ranitidine products[162](index=162&type=chunk)[164](index=164&type=chunk) [Item 1A. Risk Factors](index=65&type=section&id=Item%201A.%20Risk%20Factors) The report refers to the 2024 Form 10-K for detailed risk factors, noting no new or materially changed risks in this quarterly report - For a detailed discussion of risk factors, the report refers to the 'Risk Factors' section in the company's 2024 Form 10-K[283](index=283&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=65&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales occurred, but the company repurchased 9,022 common shares for tax withholding on restricted stock awards - There were no sales of unregistered securities during the reporting period[284](index=284&type=chunk) Issuer Purchases of Equity Securities (Q2 2025) | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April 1 - April 30, 2025 | 1,030 | $69.55 | | May 1 - May 31, 2025 | 7,892 | $59.84 | | June 1 - June 30, 2025 | 100 | $62.56 | | **Total** | **9,022** | **$60.98** | - The shares purchased were acquired from employees to satisfy tax withholding obligations related to the vesting of restricted stock awards and were not part of a formal repurchase program[286](index=286&type=chunk) [Item 5. Other Information](index=67&type=section&id=Item%205.%20Other%20Information) A Rule 10b5-1 trading plan was adopted by Christopher Mutz on June 16, 2025, for potential stock sales from January 7 to March 20, 2026 - On June 16, 2025, Christopher Mutz, SVP, Head of Rare Disease, adopted a Rule 10b5-1 trading plan for the potential sale of company stock[290](index=290&type=chunk) - The trading plan is scheduled to be active from January 7, 2026, to March 20, 2026, and covers the sale of up to **4,019 shares** of common stock, plus shares from vesting RSAs and PSUs[290](index=290&type=chunk)

Core Insights - ANI Pharmaceuticals reported a record-setting quarter with all-time highs in net revenue, adjusted EBITDA, and adjusted EPS, driven by strong performance across its business units [2][11][14] - The Rare Disease segment, particularly Cortrophin Gel, showed exceptional growth, with revenues expected to account for approximately 57% of total company revenues in the second half of 2025 [2][3][11] Financial Performance - Total net revenues for Q2 2025 reached $211.4 million, a 53.1% increase year-over-year, with organic growth of 37.0% [11][14] - Rare Disease revenues increased 111.3% to $104.0 million, with Cortrophin Gel contributing $81.6 million, a 66.0% increase from the previous year [11][15] - Generics revenues rose 22.1% year-over-year to $90.3 million, supported by new product launches and operational excellence [12][15] Business Highlights - Cortrophin Gel saw the highest number of new patient starts since its launch, with growth across various therapeutic areas including ophthalmology and pulmonology [3][4] - The launch of a pre-filled syringe for Cortrophin Gel in April 2025 has generated strong interest and is expected to drive future prescription demand [5] - The Company advanced initiatives for ILUVIEN and YUTIQ, achieving $22.3 million in revenues, while also enhancing its sales team and marketing efforts [6][11] Guidance and Expectations - ANI Pharmaceuticals has increased its 2025 guidance, projecting total net revenues between $818 million and $843 million, with adjusted EBITDA expected to be between $213 million and $223 million [22][23] - Rare Disease revenues are anticipated to represent approximately 50% of total company revenues in 2025, with Cortrophin Gel projected to generate $322 million to $329 million [11][23] Operational Metrics - Adjusted non-GAAP EBITDA for Q2 2025 was $54.1 million, reflecting a 62.8% increase year-over-year [20] - The Company reported a diluted GAAP income per share of $0.36, compared to a net loss of $0.14 per share in the prior year [19][51]

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]