Key Takeaways ANIP shares are up 53% YTD on strong Q3 results and higher full-year 2025 guidance.Rare disease sales jumped over 100% Y/Y, led by surging demand for Cortrophin Gel.Generics rose 27% Y/Y, though Q4 will face tougher competition and lower volumes.Shares of ANI Pharmaceuticals (ANIP) have surged 53% so far this year compared with the industry’s 15% growth. The stock has also outperformed the sector and the S&P 500 during the same period, as shown in the chart below.ANIP Stock Outperforms Industr ...

PRINCETON, N.J., Nov. 11, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference – London on Tuesday, November 18, at 3:00 p.m. GMT/10:00 a.m. ET. The live and archived fireside chat will be accessible from the Company’s website at www.anipharmaceuticals.com, under the Investors section under Events and Presentations. The replay of th ...

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]

Acquisition and Expansion - On September 16, 2024, the company completed the acquisition of Alimera Sciences, adding the ILUVIEN® and YUTIQ® products to its portfolio, which are approved for treating diabetic macular edema and non-infectious uveitis, respectively[210]. - The acquisition of Alimera is expected to strengthen the Rare Disease business and expand the company's footprint in Europe, Asia, and the Middle East[214]. - The company incurred approximately $13.2 million in transaction and integration costs related to the Alimera acquisition during the nine months ended September 30, 2024[226]. - The company plans to continue expanding its Rare Disease business through organic growth and acquisitions, focusing on niche opportunities[215]. - The company repaid $72.5 million of Alimera's debt as part of the merger[223]. - Each contingent value right (CVR) from the Alimera acquisition entitles holders to milestone payments based on net revenues exceeding $140 million in 2026 and $160 million in 2027[224]. - The company extended its partnership with Alliance Medical Products, Inc. to support the transition to ILUVIEN and expanded manufacturing capacity through the addition of a second manufacturing line[216]. Financial Performance - Net revenues for Q3 2025 were $227.8 million, a 53.6% increase from $148.3 million in Q3 2024, driven by growth in Rare Disease and Brands[238]. - Rare Disease total net revenues reached $118.5 million in Q3 2025, up 109.9% from $56.4 million in Q3 2024, primarily due to increased sales of Cortrophin Gel and a full quarter of sales from ILUVIEN[236]. - Operating income for Q3 2025 was $36.2 million, compared to a loss of $20.5 million in Q3 2024, marking a substantial turnaround[234]. - Net income for Q3 2025 was $26.6 million, compared to a loss of $24.2 million in Q3 2024, indicating a significant improvement in profitability[234]. - For the three months ended September 30, 2025, total net revenue was $636.3 million, an increase of 50.1% compared to $423.8 million for the same period in 2024[253]. - Rare Disease total net revenues reached $291.4 million, up 104.4% from $142.6 million in the same period last year, driven by increased volume of Cortrophin Gel and sales from ILUVIEN and YUTIQ[253]. Expenses and Costs - Cost of sales for Q3 2025 increased to $93.4 million, a 48.1% rise from $63.1 million in Q3 2024, attributed to significant growth in sales volumes[240]. - Research and development expenses increased by 21.5% to $12.3 million in Q3 2025 from $10.1 million in Q3 2024[244]. - Selling, general, and administrative expenses decreased by 3.1% to $76.7 million in Q3 2025 from $79.1 million in Q3 2024[244]. - The cost of sales as a percentage of net revenues decreased to 41.0% in Q3 2025 from 42.5% in Q3 2024, primarily due to the non-recurrence of inventory step-up costs[241]. - Cost of sales increased to $241.0 million, a rise of 41.8% from $169.9 million in the prior year, attributed to significant growth in sales volumes[257]. - Total other operating expenses increased to $318.9 million for the nine months ended September 30, 2025, up from $248.9 million in 2024, representing a 28.1% increase[259]. - Research and development expenses rose to $39.4 million, a 41.1% increase from $27.9 million in 2024, driven by ongoing and new projects in Rare Disease and Generics[259]. - Selling, general, and administrative expenses increased by 30.6% to $235.0 million from $179.9 million, primarily due to higher employment costs and investments in Rare Disease sales and marketing[259]. - Depreciation and amortization expenses were $68.8 million, up 52.5% from $45.1 million, mainly due to amortization of acquired intangible assets ILUVIEN and YUTIQ[259]. Cash Flow and Financing - Net cash provided by operating activities was $154.9 million for the nine months ended September 30, 2025, an increase of $106.7 million compared to $48.2 million in the same period of 2024[284]. - Net cash used in investing activities for the nine months ended September 30, 2025 was $32.9 million, significantly lower than $394.0 million in the same period of 2024, primarily due to the acquisition of Alimera[285]. - Net cash used in financing activities for the nine months ended September 30, 2025 was $5.3 million, compared to $269.9 million provided in the same period of 2024[286]. - The company entered into a new credit agreement providing for a senior secured term loan facility of $325.0 million and a revolving credit facility of $75.0 million[265]. - The company drew the full $325.0 million of Term Loan A on September 16, 2024, to finance the acquisition of Alimera[266]. - The company issued $275.0 million of Convertible Senior Notes due 2029, with net proceeds of approximately $306.8 million used to repay existing senior secured credit agreements[270]. - The cash interest rate under the Term Loan A was approximately 6.76% as of September 30, 2025[266]. - The Company believes its financial resources will be sufficient to meet working capital requirements and debt obligations for at least the next 12 months[282]. Tax and Other Financial Metrics - The effective tax rate for the three months ended September 30, 2025, was 21.3%, with an income tax expense of approximately $7.2 million[250]. - An income tax expense of approximately $13.5 million was recorded for the nine months ended September 30, 2025, with an effective tax rate of 20.9%[263]. - The company recognized a gain of $14.5 million for contingent consideration fair value adjustments during the three months ended September 30, 2025[247]. - Interest expense, net increased by $2.4 million, primarily due to higher interest expenses related to the New Credit Agreement and Convertible Senior Notes[252]. - The company recorded an unrealized gain on investment in equity securities of approximately $3.1 million for the three months ended September 30, 2025[252]. - Cost of sales as a percentage of net revenues decreased to 37.9% from 40.1% year-over-year, reflecting a shift in product mix[258]. - The Company paid an upfront payment of $75.0 million to EyePoint for a product rights agreement, with additional quarterly payments totaling $7.5 million during 2024[280]. - The Company expects to pay royalties to EyePoint at 30% of annual U.S. net sales of certain products starting at $70.0 million in 2025, increasing annually thereafter[281]. - The Company used approximately $40.6 million of the net proceeds from the offering of the Notes to pay premiums on the Capped Calls[277]. - The Capped Calls cover approximately 4.3 million shares of the Company's common stock, aimed at reducing potential dilution upon conversion of the Notes[278].

Core Insights - ANI Pharmaceuticals reported a strong third quarter with record revenue and adjusted EBITDA, highlighting the growth in its Rare Disease and Generics business units [2][7] - The company anticipates that net revenues from its Rare Disease business will account for approximately 50% of total revenues in 2025, driven by the success of Cortrophin Gel [2][7] - ANI has raised its financial guidance for 2025, expecting total net revenue growth of 39% to 42% year-over-year and adjusted EBITDA growth of 42% to 46% [2][7] Financial Performance - Total net revenues for Q3 2025 reached $227.8 million, a 53.6% increase compared to Q3 2024 [6][7] - Rare Disease total net revenues increased by 109.9% to $118.5 million, with Cortrophin Gel net revenues growing by 93.8% to $101.9 million [9][10] - Generics net revenues were $94.4 million, reflecting a 20.6% increase year-over-year, attributed to a successful partnered generic launch [4][10] Business Highlights - Cortrophin Gel's growth was supported by increased demand and the highest number of new patient starts since its launch, with significant contributions from specialties like neurology and rheumatology [8][9] - ILUVIEN net revenues were $16.6 million, impacted by reduced access for Medicare patients and ongoing adoption efforts [8][9] - The company is focused on advancing its Rare Disease business to drive long-term shareholder value and improve patient access [2][7] Guidance and Future Outlook - ANI has updated its full-year 2025 guidance, projecting total net revenues between $854 million and $873 million, with adjusted non-GAAP EBITDA expected to be between $221 million and $228 million [17][18] - The company anticipates gross margins to be between 61.0% and 62.0% for the full year [18] - Adjusted non-GAAP diluted earnings per share are expected to range from $7.37 to $7.64 [17][18]

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