Key Takeaways ANI Pharmaceuticals' rare disease revenues more than doubled to $291M in the first nine months.Cortrophin Gel sales rose 70% to $236M, supported by broader demand and expanded field efforts.ANIP cut its 2025 outlook for Iluvien and Yutiq but sees the franchise returning to growth in 2026.ANI Pharmaceuticals’ (ANIP) rare disease franchise has emerged as a major growth catalyst in 2025, with segment revenues more than doubling year over year to $291 million in the first nine months. The company ...

ANI Pharmaceuticals (ANIP) has been beaten down lately with too much selling pressure. While the stock has lost 15% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier.We use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscillator that measures the speed and change ...

ANI Pharmaceuticals Conference Call Summary Company Overview - ANI Pharmaceuticals is a growing, profitable biopharmaceutical company focused on rare diseases with three business units: rare disease, generics, and brands [2][3] Core Business Segments - **Rare Disease Business**: - Primary growth driver with two key assets: Purified Cortrophin Gel and ILUVIEN - Purified Cortrophin Gel is used for autoimmune diseases across multiple therapeutic areas [2][3] - ILUVIEN targets retinal diseases, specifically diabetic macular edema and non-infectious uveitis [2] - **Generics Business**: - Strong growth over the past four to five years, supported by R&D and U.S.-based manufacturing [3] Financial Guidance for 2025 - Total company revenues projected at $854 million to $873 million, reflecting a 39%-42% year-over-year growth [4] - Adjusted non-GAAP EBITDA expected to be $221 million to $228 million, indicating a 42%-46% year-over-year growth [4] - Adjusted non-GAAP EPS forecasted at $7.37 to $7.64, also showing a 42%-46% year-over-year growth [4] Growth Strategy - Transition to focus on rare diseases initiated by the current CEO, with significant growth in the rare disease segment [5] - Purified Cortrophin Gel revenue guidance for 2025 is $347 million to $354 million, representing a 75%-78% growth from the previous year [5][6] Market Potential and Demand - Addressable patient population for Purified Cortrophin Gel is substantial, with specific numbers cited for conditions like acute gouty arthritis [14][15] - The company has expanded its sales force to reach more prescribers, resulting in significant growth [17] Competitive Landscape - Both ANI and competitor Mallinckrodt have seen strong growth, validating the market for ACTH therapies [18][24] - The previous peak sales for the category were around $1.2 billion, and current projections suggest potential for surpassing this figure [24][25] Access and Reimbursement - The IRA Part D redesign provided a moderate tailwind for access, lowering out-of-pocket costs for patients [33] - Ongoing efforts to improve access through partnerships with payers and patient assistance programs [26][28] ILUVIEN Update - 2025 is viewed as a reset year for ILUVIEN, with expectations for growth driven by a larger addressable patient population and improved sales force engagement [36][37] - Anticipated revenue for ILUVIEN in 2025 is $73 million to $77 million, with growth expected in subsequent years [37][39] Conclusion - ANI Pharmaceuticals is positioned for significant growth in the rare disease market, with strong financial projections and a strategic focus on expanding its product offerings and market access initiatives [4][25][39]

Core Insights - ANI Pharmaceuticals (ANIP) shares have increased by 53% year-to-date, significantly outperforming the industry growth of 15% [1][4] - The company's strong financial performance has led to an upward revision of its full-year 2025 guidance, with expected sales between $854 million and $873 million and EPS in the range of $7.37-$7.64 [4][8] Financial Performance - ANIP reported third-quarter 2025 results that exceeded estimates for both revenue and earnings [4] - The company anticipates annual sales growth of 39-42% and earnings growth of 42-47% based on the revised outlook [4] Rare Disease Portfolio - Sales from the rare disease segment have surged over 100% year-over-year, reaching $291 million in the first nine months of 2025, primarily driven by demand for Cortrophin Gel [6][8] - Cortrophin Gel sales increased by 70% year-over-year to $236 million, supported by expanded sales efforts and broader prescriber adoption [7][9] Generics Business - Sales from the generics unit rose 27% year-over-year to over $283 million in the first nine months of 2025, aided by new product launches and temporary exclusivity [11] - Despite strong growth, the generics market faces increased competition, which may pressure pricing and margins [12] Market Position and Valuation - ANIP is currently trading at a price/sales (P/S) ratio of 2.16, lower than the industry average of 2.40, indicating a potential for further upside [13] - The company has maintained consistent EPS estimates for 2025 while slightly increasing those for 2026 [15] Future Outlook - The company is well-positioned for sustained profitability and growth, particularly in its rare disease segment and improving ophthalmology products [16][17] - ANIP's management has raised financial guidance for the fourth time this year, reflecting confidence in operational execution [17][18]

Core Viewpoint - ANI Pharmaceuticals, Inc. will participate in the Jefferies Global Healthcare Conference, highlighting its commitment to engaging with investors and stakeholders in the healthcare sector [1]. Company Overview - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics aimed at improving patient lives [3]. - The company operates in three main segments: Rare Disease, Generics, and Brands, with a focus on sustainable growth through its diverse product offerings in various therapeutic areas including ophthalmology, rheumatology, nephrology, neurology, and pulmonology [3]. Event Details - The fireside chat featuring CEO Nikhil Lalwani is scheduled for November 18 at 3:00 p.m. GMT/10:00 a.m. ET, and will be accessible live and archived on the company's website for 90 days [1][2].

Financial Performance - Record quarterly net revenues of $227.8 million, an increase of 53.6% year-over-year[4] - Purified Cortrophin Gel net revenues of $101.9 million, an increase of 93.8% year-over-year[4] - Adjusted non-GAAP EBITDA of $59.6 million, an increase of 69.8% year-over-year[4] - Generics net revenues of $94.4 million, an increase of 20.6% year-over-year, driven by a successful partnered generic launch[8] - GAAP net income attributable to common shareholders of $26.3 million, or $1.13 per diluted share, compared to a net loss of $24.6 million in the prior year[17] - The company reported a net income of $26.6 million for Q3 2025, compared to a net loss of $24.2 million in Q3 2024[50] - Net income for the nine months ended September 30, 2025, was $50,847,000, compared to a loss of $(8,246,000) in the same period of 2024[56] - Adjusted non-GAAP net income available to common shareholders for the nine months ended September 30, 2025, was $112,643,000, compared to $70,024,000 in 2024, reflecting a 60% increase[58] Revenue Guidance - Total net revenue guidance for 2025 raised to $854 million to $873 million, representing a year-over-year growth of 39% to 42%[20] - Rare Disease net revenues expected to represent approximately 50% of total Company net revenues in 2025[4] - Cortrophin Gel net revenues guidance for 2025 set at $347 million to $352 million, indicating a growth of 75% to 78% year-over-year[20] - Adjusted non-GAAP diluted earnings per share guidance for 2025 raised to $7.37 to $7.64, reflecting a growth of 42% to 47% year-over-year[20] Cash and Assets - As of September 30, 2025, the Company had $262.6 million in unrestricted cash and cash equivalents[19] - Total current assets increased to $698,402 thousand as of September 30, 2025, up from $527,684 thousand on December 31, 2024, representing a 32.3% growth[52] - Cash and cash equivalents significantly increased to $262,610 thousand as of September 30, 2025, compared to $144,861 thousand on December 31, 2024, marking an 81.5% rise[52] - Accounts receivable, net, grew to $252,617 thousand as of September 30, 2025, from $221,726 thousand on December 31, 2024, a 13.9% increase[52] - Total stockholders' equity increased to $505,817 thousand as of September 30, 2025, up from $403,680 thousand on December 31, 2024, representing a 25.3% growth[52] Expenses - Non-GAAP research and development expenses for Q3 2025 were $12.3 million, up from $10.1 million in Q3 2024[50] - Non-GAAP selling, general, and administrative expenses for Q3 2025 were $76.7 million, slightly down from $79.1 million in Q3 2024[50] - Selling, general, and administrative expenses for the nine months ended September 30, 2025, were $241,041,000, up from $169,930,000 in 2024, a 42% increase[56] - Research and development expenses for the nine months ended September 30, 2025, totaled $234,955,000, compared to $179,917,000 in 2024, reflecting a 30% increase[56] - Stock-based compensation for the nine months ended September 30, 2025, was $28,161,000, compared to $22,283,000 in 2024, a 26% increase[58] - Litigation expenses for the nine months ended September 30, 2025, were $12,038,000, significantly higher than $4,738,000 in 2024, indicating a 154% increase[58] Operational Highlights - Operating income for the nine months ended September 30, 2025, was $76.3 million, compared to $5.0 million in the same period of 2024[50] - Adjusted non-GAAP EBITDA for the three months ended September 30, 2025, was $59,601 thousand, up from $35,104 thousand in 2024, reflecting a 69.9% increase[55] - Adjusted non-GAAP EBITDA for the nine months ended September 30, 2025, was $164,427,000, up from $105,961,000 in 2024, representing a 55% increase[56] - Adjusted diluted earnings per share for the nine months ended September 30, 2025, was $5.54, compared to $3.57 in 2024, indicating a 55% growth[58] Future Outlook - The company is focused on sustainable growth through its Rare Disease, Generics, and Brands business segments[43] - The company plans to continue focusing on market expansion and new product development to drive future growth[54] - The company did not provide a reconciliation for the forward-looking full year 2025 adjusted diluted earnings per share guidance due to insufficient information[35]

Core Insights - ANI Pharmaceuticals reported Q3 CY2025 results exceeding market revenue expectations, with a year-on-year sales increase of 53.6% to $227.8 million [1][3] - The company's full-year revenue guidance of $863.5 million at the midpoint is 1.8% above analysts' estimates, and its non-GAAP profit of $2.04 per share surpassed consensus estimates by 15.2% [1][5] Financial Performance - Revenue for Q3 was $227.8 million, beating analyst estimates of $214.1 million, reflecting a 53.6% year-on-year growth and a 6.4% beat [5] - Adjusted EPS was reported at $2.04, exceeding analyst estimates of $1.77 by 15.2% [5] - Adjusted EBITDA reached $59.6 million, surpassing analyst estimates of $55.24 million, with a margin of 26.2% [5] - The company raised its full-year revenue guidance to $863.5 million from $830.5 million, marking a 4% increase [5] - Full-year Adjusted EPS guidance was lifted to $7.51 at the midpoint, a 4.7% increase [5] - EBITDA guidance for the full year is set at $224.5 million at the midpoint, above analyst estimates of $221.9 million [5] - Operating margin improved to 15.9%, up from -13.8% in the same quarter last year [5] - Market capitalization stands at $1.87 billion [5] Business Segments and Growth Drivers - The significant growth was attributed to strong performance in the Rare Disease and Generics segments, with Cortrophin Gel nearly doubling net revenue compared to the prior year [3] - The company experienced record new patient starts and expanded prescriber adoption, particularly in pulmonology and ophthalmology [3] - Management emphasized strong underlying demand and addressable patient populations as key drivers of success [3] Future Outlook - Updated guidance reflects expectations of continued growth, particularly from the Rare Disease portfolio, with a focus on Cortrophin Gel [4] - The company aims to expand clinical evidence, invest in commercial initiatives, and enhance patient convenience [4] - Management expressed confidence in the multi-year growth trajectory of Cortrophin and acknowledged ongoing efforts to support ILUVIEN's adoption [4] - Future business development opportunities are anticipated to expand the Rare Disease segment [4]

Core Viewpoint - Euronext is reducing the acceptance threshold for its bid to acquire control of the Athens stock exchange from 67% to 50% plus one share of the voting rights [1] Group 1 - The decision to lower the acceptance threshold aims to facilitate the acquisition process and increase the likelihood of securing control over the Athens stock exchange [1] - This strategic move reflects Euronext's commitment to expanding its operations and influence in the European financial market [1]

Financial Data and Key Metrics Changes - Company revenues grew by 54% year over year, reaching $227.8 million in Q3 2025, with adjusted EBITDA growth of 70% year over year [4][20] - Adjusted non-GAAP diluted earnings per share increased to $2.04 from $1.34 in the prior year period [24] - The company raised its 2025 financial guidance, expecting net revenues of $854 million to $873 million, up from previous guidance of $818 million to $843 million [26][28] Business Line Data and Key Metrics Changes - Rare disease revenues were $118.5 million, up 109.9% from the prior year, with Cortrophin Gel revenues at $101.9 million, up 93.8% [20][21] - Revenues from the generics segment increased by 19.3% to $98.7 million, driven by a successful partner generic product launch [22][24] - Iluvien net revenues were $16.6 million, with expectations for modestly lower demand in the fourth quarter due to normalization trends [21][27] Market Data and Key Metrics Changes - The ACTH market is expected to grow approximately 40% to $957 million in 2025, with Cortrophin projected to grow by 75%-78% [8] - The addressable patient population for acute gouty arthritis is estimated at 285,000 patients, indicating significant growth potential for Cortrophin Gel [8][35] Company Strategy and Development Direction - The company aims to grow its rare disease business, with Cortrophin Gel as a top strategic priority, focusing on clinical evidence generation and enhancing patient convenience [5][11] - The company is exploring inorganic opportunities to expand its rare disease business while continuing to support its genetics and brands business [11][47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong multi-year growth trajectory of Cortrophin Gel, driven by increased demand and a growing prescriber base [7][35] - The company anticipates continued strong momentum in Cortrophin and positive impacts from initiatives to grow Iluvien in 2026 [11][72] Other Important Information - The company ended Q3 2025 with $262.6 million in unrestricted cash, up from $217.8 million at the end of Q2 [25] - Non-GAAP gross margin was 59.2%, a slight decrease from the prior year, primarily due to product mix [24] Q&A Session Summary Question: Impact of Medicare Part D redesign on Cortrophin growth - Management noted a modest tailwind from the redesign, improving affordability and access for patients, but tempered by mandatory Medicare manufacturer payments [34] Question: Details on the new partner generic product - The company did not specify the name of the partner generic but indicated it was launched successfully, with expectations of competition entering the market [38] Question: Growth trajectory in pulmonology for Cortrophin - Management acknowledged pulmonology as an important area with significant growth potential, although it currently represents a smaller portion of the overall mix [44] Question: Durability of Cortrophin Gel against potential generic competition - Management expressed confidence in the long-term durability of Cortrophin Gel, citing the complexity of developing a generic version [62] Question: Challenges of label expansion in the ACTH category - Management indicated that any label expansion would require a phase three clinical trial, and they are focused on generating evidence to support treatment guidelines [66]

Core Insights - ANI Pharmaceuticals reported quarterly earnings of $2.04 per share, exceeding the Zacks Consensus Estimate of $1.74 per share, and showing an increase from $1.34 per share a year ago, resulting in an earnings surprise of +17.24% [1] - The company achieved revenues of $227.81 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 7.81%, and up from $148.33 million year-over-year [2] - ANI shares have increased by approximately 63.2% since the beginning of the year, significantly outperforming the S&P 500's gain of 14.3% [3] Earnings Outlook - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The trend of estimate revisions for ANI was favorable prior to the earnings release, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Future Estimates - The current consensus EPS estimate for the upcoming quarter is $2.05 on revenues of $225.92 million, while for the current fiscal year, the estimate is $7.29 on revenues of $845.72 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which ANI belongs, is currently ranked in the top 37% of over 250 Zacks industries, suggesting a favorable outlook as the top 50% of Zacks-ranked industries tend to outperform the bottom 50% by more than 2 to 1 [8]