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 ...

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].

Exhibit 99.1 FOR IMMEDIATE RELEASE ANI Pharmaceuticals Reports Record Third Quarter 2025 Financial Results and Raises 2025 Guidance PRINCETON, N.J., November 7, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the third quarter ended September 30, 2025. "ANI had another strong quarter in which we delivered record revenue and adjusted EBITDA, underscoring the strength of our Rare Disease and Generics business ...

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]

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh. ...