Summary of ANI Pharmaceuticals FY Conference Call Company Overview - ANI Pharmaceuticals is a publicly traded company listed on Nasdaq under the ticker ANIP [1] Key Points and Arguments - The conference call took place on September 8, 2025, at 09:00 AM ET, indicating a focus on the company's financial performance for the fiscal year [1] - Specific financial metrics and performance indicators were discussed, although detailed figures were not provided in the excerpt [1] - The company likely addressed its strategic initiatives and future outlook, which are critical for investors [1] Important but Possibly Overlooked Content - The call may have included insights into market trends affecting the pharmaceutical industry, which could impact ANI Pharmaceuticals' operations and growth [1] - Potential risks and challenges faced by the company in the current economic environment were likely discussed, although specifics are not available in the excerpt [1] This summary captures the essential elements of the conference call, focusing on the company and industry context without delving into specific financial data or detailed discussions that were not included in the provided content.

ANI Pharmaceuticals FY Conference Summary Company Overview - ANI Pharmaceuticals operates in the biopharmaceutical sector, focusing on rare disease therapeutics, generics, and branded products [2][3] - The company aims to build a high-growth, profitable business while serving patients and improving lives [2] Key Business Segments 1. **Rare Disease** - Primary growth driver with two main products: Purified Cortrophin Gel and ILUVIEN [2][3] - Plans to expand through mergers and acquisitions [2] - Expected to account for 57% of H2 2025 revenues [8] 2. **Generics** - Growth driven by R&D capabilities and U.S.-based manufacturing [3][24] - Achieved record revenues in Q2 2025, with a 22% year-over-year increase [24] 3. **Brands** - Generates high margins and strong cash flows, supporting investments in rare disease [3] Financial Performance - **2025 Guidance**: - Net revenues projected between $818 million to $843 million, representing a 33% to 37% year-over-year growth [3][7] - Adjusted non-GAAP EBITDA expected to be between $213 million to $223 million, indicating a 37% to 43% year-over-year growth [7] - Adjusted non-GAAP EPS forecasted at $6.98 to $7.35, reflecting a 34% to 45% year-over-year growth [7] - **Historical Growth**: - Revenues grew from $316 million in 2022 to a projected $818 million to $843 million in 2025, representing a 38% CAGR [4] - Adjusted non-GAAP EBITDA increased from $56 million in 2022 to a projected $213 million to $223 million in 2025, reflecting a 57% CAGR [4] Product Highlights 1. **Purified Cortrophin Gel** - Key growth asset with expected sales of $326 million in its fourth year [4] - Significant growth driven by new patient starts and demand for new presentations [5][6] - Addressable patient populations are significantly underpenetrated, indicating strong multi-year growth potential [12][18] 2. **ILUVIEN and YUTIQ** - Durable ocular therapies with significant growth potential in underserved patient populations [19][21] - Recent label expansion for chronic non-infectious uveitis and diabetic macular edema [19][20] - Expected revenues between $87 million to $93 million for 2025 [21] Market Dynamics - The overall ACTH market was approximately $600 million in 2022 and is projected to grow to $933 million by 2025 [10][12] - The company maintains a strong commitment to U.S. manufacturing, with over 90% of revenues derived from domestically produced products [6] Strategic Initiatives - Continued investment in R&D to support the use of Cortrophin Gel, including a phase IV clinical trial for acute gouty arthritis [15] - Expansion of sales teams in targeted therapeutic areas to capture revenue synergies [14] - Focus on enhancing patient convenience through new product presentations, such as the prefilled syringe [15] Conclusion - ANI Pharmaceuticals is positioned for strong growth in the rare disease sector, with a strategic focus on expanding its product offerings and addressing underpenetrated markets [25] - The generics business is also expected to contribute significantly to overall revenue growth, supported by operational excellence and cost management strategies [25]

Company Overview - ANI Pharmaceuticals (ANIP) currently holds a Momentum Style Score of A, indicating strong momentum characteristics [2] - The company has a Zacks Rank of 1 (Strong Buy), suggesting a favorable outlook compared to the market [3] Price Performance - Over the past week, ANIP shares have increased by 4.05%, outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 0.67% [5] - In a longer time frame, ANIP's shares have surged by 43.49% over the past month, while the industry only saw a 0.85% increase [5] - Over the last quarter, ANIP shares have risen by 50.94%, and over the past year, they have gained 46.49%, significantly outperforming the S&P 500's increases of 9.72% and 16.49%, respectively [6] Trading Volume - The average 20-day trading volume for ANIP is 737,319 shares, which serves as a bullish indicator when combined with rising stock prices [7] Earnings Outlook - In the past two months, 6 earnings estimates for ANIP have been revised upwards, with no downward revisions, leading to an increase in the consensus estimate from $6.51 to $7.25 [9] - For the next fiscal year, 6 estimates have also moved higher without any downward revisions [9] Conclusion - Given the strong momentum indicators and positive earnings outlook, ANIP is positioned as a solid momentum pick and is recommended for consideration in the near term [11]

Core Viewpoint - ANI Pharmaceuticals, Inc. is actively engaging with investors through presentations at two upcoming conferences, highlighting its commitment to transparency and investor relations [1]. 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, targeting areas such as ophthalmology, rheumatology, nephrology, neurology, and pulmonology [2]. Upcoming Events - ANI Pharmaceuticals will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 9:00 am ET [1]. - The company will also participate in the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, at 1:50 pm ET [1]. - Live and archived webcasts of these presentations will be available on the company's website for 90 days [1].

Core Viewpoint - ANI Pharmaceuticals has experienced significant stock performance, with a 36.5% increase over the past month and a 64.9% rise since the beginning of the year, outperforming the Zacks Medical sector and the Zacks Medical - Biomedical and Genetics industry [1][2]. Financial Performance - ANI has consistently exceeded earnings expectations, reporting an EPS of $1.8 against a consensus estimate of $1.38 in its last earnings report [2]. - For the current fiscal year, ANI is projected to achieve earnings of $7.25 per share on revenues of $840.7 million, reflecting a 39.42% increase in EPS and a 36.84% increase in revenues [3]. - The next fiscal year forecasts earnings of $7.74 per share on revenues of $904.39 million, indicating year-over-year changes of 6.64% and 7.58%, respectively [3]. Valuation Metrics - ANI's current valuation metrics show a Value Score of B, with Growth and Momentum Scores of A, resulting in a combined VGM Score of A [6]. - The stock trades at 12.6 times the current fiscal year EPS estimates, below the peer industry average of 20.1 times, and at 12 times trailing cash flow compared to the peer group's average of 16.1 times [6]. Zacks Rank - ANI holds a Zacks Rank of 1 (Strong Buy), driven by rising earnings estimates, which aligns with the recommendation for investors to select stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B [7].

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]