Core Insights - ANI Pharmaceuticals (ANIP) and Teva Pharmaceuticals (TEVA) are both key players in the pharmaceutical sector, focusing on generic and specialty medications [1][2] - ANIP's growth is primarily driven by its rare disease therapies, particularly Cortrophin Gel, while TEVA operates as a global leader in both branded and generic drugs [1][10] Summary of ANI Pharmaceuticals (ANIP) - ANIP has shown strong financial performance, particularly in its rare disease and generics segments [3] - The rare disease franchise, led by Cortrophin Gel, is the main growth driver, with projected sales of approximately $348 million for 2025, reflecting a 76% year-over-year increase [4] - For 2026, ANIP anticipates Cortrophin Gel sales to reach between $540 million and $575 million, indicating a 55-65% increase over 2025 [5] - The company also expects its recently acquired ophthalmology assets to contribute around $75 million in 2025, with growth anticipated in 2026 [6] - Total projected revenues for ANIP in 2026 are estimated to be between $1.055 billion and $1.115 billion, with about 60% from rare disease products [7] - The generics segment is expected to contribute 40% of revenues, with plans to launch 10-15 new generic products annually [8] - Competitive pressure is increasing in the rare disease market, particularly from Keenova Therapeutics' Acthar Gel, which has raised its sales growth outlook [9] Summary of Teva Pharmaceuticals (TEVA) - TEVA is the largest generic drug company globally, holding a 7% market share in the U.S. generics market [12] - The company has been expanding its biosimilars portfolio, with several successful launches and a goal to double biosimilars sales by 2027 [15] - TEVA maintains a diversified portfolio of branded products, with growing market shares for newer drugs like Austedo, Ajovy, and Uzedy [16] - However, the generics business has faced challenges, including competitive pressure and a decline in certain markets [17] - TEVA's revenue estimates for 2026 are expected to remain flat, with EPS growth projected at 6% [21] Financial Performance and Valuation - Over the past year, ANIP shares have increased by 48%, while TEVA shares have risen by 49%, outperforming the industry average of 39% [22] - ANIP trades at a price/earnings (P/E) ratio of 12.74, slightly higher than TEVA's 12.39, indicating a premium valuation for ANIP [23] Investment Outlook - ANIP's sales momentum and earnings growth provide a competitive edge over TEVA, which is experiencing margin pressures [27] - ANIP holds a Zacks Rank of 2 (Buy), while TEVA has a Zacks Rank of 3 (Hold), further supporting ANIP's favorable investment position [28]

Key Takeaways ANIP shares rose after the company issued full-year 2026 guidance that beat Wall Street expectations.ANI Pharma forecasts 2026 sales of $1.055-$1.115B and EPS of $8.83-$9.34, with ~60% from rare diseases.ANIP expects Cortrophin Gel sales of $540-$575M in 2026, driven by higher demand and prescriber adoption.Shares of ANI Pharmaceuticals (ANIP) have risen 7% in the past week, all thanks to the recently announced financial guidance for the full year 2026 that surpassed Wall Street expectations.A ...

Core Insights - ANI Pharmaceuticals is transforming into a leading rare disease company, focusing on high growth and profitability [2] - The company projects over $1 billion in revenue by 2026, representing a 26% year-on-year growth compared to 2025, with a significant 39% growth anticipated for the year prior [3] - The rare disease segment is expected to account for approximately 60% of total revenues, driven by the lead asset, purified Cortrophin Gel, which offers substantial multiyear growth opportunities [3] Financial Performance - The generics business is generating strong cash flows due to superior R&D capabilities and operational execution, alongside U.S. manufacturing [3] - The virtuous cycle of growth is created by EBITDA and cash flows from both generics and brands, enabling further investment in the rare disease sector [3]

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ANI Pharmaceuticals Conference Call Summary Company Overview - ANI Pharmaceuticals is a profitable, high-growth biopharmaceutical organization focused on transforming into a leading rare disease company [1][17] - Projected revenue for 2026 is over $1 billion, representing a 26% year-on-year growth compared to 2025 [1] Key Financial Highlights - 2025 net revenues grew by more than 39% to between $854 million and $873 million [2] - Adjusted non-GAAP EBITDA for 2025 increased by over 42% to between $221 million and $228 million [2] - 2026 guidance includes net revenue of $1,055 million to $1,115 million, indicating 24%-28% growth [5] - Adjusted non-GAAP EBITDA guidance for 2026 is $275 million to $290 million, representing 24%-27% growth [5] Rare Disease Business Focus - The rare disease segment is expected to account for approximately 60% of total revenues in 2026 [1][17] - Purified Cortrophin Gel, the lead asset, is projected to generate net revenues of $540 million to $575 million, reflecting 55%-65% growth [5][11] - The rare disease business expanded from 0% of sales in 2021 to nearly 60% in 2026 [6] Growth Drivers - Significant growth in the rare disease business driven by unmet medical needs across various indications including nephrology, neurology, rheumatology, and pulmonology [3][6] - A dedicated 90-person organization will be established to focus on acute gouty arthritis flares by mid-2026 [3][10] - The ACTH market, which includes Cortrophin, grew 45% year-over-year in 2025, reaching approximately $992 million [7] Generics Business Performance - The generics segment continues to deliver strong cash flows, with a robust pipeline for 10-15 new product launches annually [4][16] - Generics business generated low 20% growth in 2025, with expectations for similar performance in 2026 [34] Strategic Initiatives - Continued execution in the generics business while investing in the rare disease segment [4][17] - Focus on enhancing patient convenience and expanding market access for both Cortrophin and Iluvien [4][15] - Investments in marketing and medical affairs to support Iluvien's growth, targeting a return to growth in 2026 [14][30] Market Opportunities - The addressable market for acute gouty arthritis flares is estimated at 285,000 patients, with only 8% currently receiving injectable treatments [9][11] - Iluvien has a significant growth opportunity in diabetic macular edema (DME) and chronic non-infectious uveitis, with less than 5,000 patients treated annually in the U.S. [13][30] Capital Allocation Strategy - ANI Pharmaceuticals plans to maintain a disciplined capital allocation strategy, focusing on expanding the rare disease business [4][39] - The company generated $140 million in net cash in 2025, with a cash balance of $285 million at year-end [40] Conclusion - ANI Pharmaceuticals is well-positioned for long-term growth, with a strong focus on rare diseases and a solid generics business supporting its transformation [17]

Core Insights - ANI Pharmaceuticals, Inc. (ANIP) reported a strong finish to 2025, resulting in a stock increase of approximately 10% [1] - The management outlined ambitious growth plans for the company [1] Company Overview - ANI Pharmaceuticals is focused on the biotechnology sector, particularly in drug development [1] - The company aims to innovate through unique mechanisms of action and first-in-class therapies [1] Financial Performance - The stock performance reflects positive investor sentiment following the company's recent financial results [1] - The reported growth indicates a strong market position and potential for future expansion [1]

Core Insights - ANI Pharmaceuticals, Inc. (ANIP) reported a strong finish to 2025, resulting in a stock increase of approximately 10% [1] - The management outlined ambitious growth plans for the company [1] Company Overview - ANI Pharmaceuticals is focused on the biotechnology sector, particularly in drug development [1] - The company aims to innovate through unique mechanisms of action and first-in-class therapies [1] Financial Performance - The stock performance reflects positive market reception following the company's recent financial results [1] Growth Strategy - Management has set forth an ambitious growth strategy, indicating confidence in future performance [1]

Core Viewpoint - ANI Pharmaceuticals (ANIP) shares experienced a significant rally of 10.6% due to positive financial guidance for 2026, exceeding Wall Street expectations [1][2]. Financial Performance - ANI Pharmaceuticals projects total net revenues between $1.055 billion and $1.115 billion for the full year 2026, with approximately 60% of this revenue expected from its rare disease segment [2]. - The Zacks Consensus Estimate for total net revenues was $937.71 million, indicating a substantial positive outlook from the company [2]. Earnings Expectations - The company is anticipated to report quarterly earnings of $2.02 per share, reflecting a year-over-year increase of 23.9% [3]. - Expected revenues for the upcoming quarter are $233.91 million, which represents a 22.7% increase compared to the same quarter last year [3]. Stock Performance and Trends - The consensus EPS estimate for ANI has remained unchanged over the last 30 days, suggesting stability in earnings expectations [4]. - A stock's price typically does not continue to rise without trends in earnings estimate revisions, indicating the importance of monitoring ANIP's performance moving forward [4]. - ANI Pharmaceuticals holds a Zacks Rank of 2 (Buy), indicating a favorable outlook compared to other stocks in the same industry [4]. Industry Comparison - ANI Pharmaceuticals operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Arcutis Biotherapeutics, Inc. (ARQT), has seen a decline of 5.1% in its stock price recently [4]. - Arcutis Biotherapeutics has a consensus EPS estimate of $0.02, which is a 122.2% increase from the previous year, but it currently holds a Zacks Rank of 3 (Hold) [5].

Financial Projections - Total net revenue projected to exceed $1 billion in 2026, representing a year-over-year increase of over 26%[4] - Cortrophin Gel net revenue for 2025 reached $348 million, reflecting a 76% year-over-year growth[6] - Adjusted non-GAAP EBITDA for 2025 estimated between $221 million and $228 million, showing a growth of over 42% year-over-year[6] - Adjusted non-GAAP diluted EPS for 2025 projected between $7.37 and $7.64, indicating a year-over-year increase of over 42%[6] - 2026 adjusted non-GAAP gross margin expected to be between 59.3% and 60.3%[8] - The total revenue for 2026 is projected to exceed $1 billion, representing a 26% year-over-year growth[24] Product Performance and Growth - Rare Disease business expected to account for approximately 60% of total revenues in 2026[4] - Cortrophin Gel anticipated to drive long-term growth by addressing unmet needs in nephrology, neurology, rheumatology, and pulmonology[7] - ILUVIEN net revenue for 2025 estimated at $75 million, with growth initiatives planned for 2026[6] - Rare Disease net revenues expected to grow significantly, with Cortrophin Gel and ILUVIEN contributing to this expansion[10] - Cortrophin Gel is expected to deliver over 60% year-over-year growth in 2026, contributing significantly to the company's revenue growth strategy[24] - The ACTH market is projected to reach approximately $992 million in 2025, reflecting a 45% year-over-year increase[11] Generics Business Strategy - Generics business projected to maintain a cadence of 10-15 product launches annually[7] - The company aims to launch 10-15 new products annually, investing a high single-digit percentage of Generics revenue into R&D[19] - The Generics business is expected to generate net revenues of $301 million in 2024, with a year-over-year growth rate exceeding 20%[19] - The Generics business has manufactured and supplied over 2.5 billion doses of therapeutics in the last 12 months[19] Market Research and Patient Insights - The addressable patient population for Cortrophin Gel includes approximately 285,000 patients for acute gout flares, with only 36% receiving treatment annually[13] - ANI Pharmaceuticals is focusing on expanding its addressable patient population for Cortrophin Gel, targeting conditions such as gout, multiple sclerosis, rheumatoid arthritis, sarcoidosis, and nephrotic syndrome[1] - The company has conducted extensive market research, indicating significant disease burden and treatment gaps in the U.S. for multiple sclerosis, with a prevalence rate of approximately 0.1%[5] - ANI's analysis shows that the burden of gout in the U.S. is substantial, with a notable percentage of patients experiencing frequent flares[3] - The company is actively exploring new treatment patterns for sarcoidosis, with recent studies highlighting variability in disease management across the U.S.[16] - ANI is leveraging data from multiple studies to inform its strategies for addressing steroid-resistant nephrotic syndrome, which remains a challenging area in pediatric care[21] - The company aims to enhance its product offerings by focusing on innovative therapies for chronic diseases, as indicated by its ongoing research initiatives[17] - ANI is committed to improving patient outcomes through targeted therapies, as evidenced by its focus on conditions with high unmet medical needs[19] - The company is analyzing treatment patterns and patient insights to refine its approach to managing rheumatoid arthritis, particularly in patients with low disease activity[11] - ANI's market research indicates a growing prevalence of sarcoidosis, necessitating new treatment strategies to address patient needs effectively[15] - The company is positioned to capitalize on the increasing demand for effective therapies in chronic disease management, supported by its comprehensive data analysis and research efforts[18]

Corporate Presentation January 2026 © 2026 ANI Pharmaceuticals, Inc. 1 Disclaimers Forward-Looking Statements This presentation contains forward-looking statements within the meaning of Section 27A of the Act, and Section 21E of the Securities Exchange Act of 1934, as amended. The guidance included herein is from or supplemental to the Company's press release on January 12, 2026. The Company is neither reconfirming this guidance as of the date of this investor presentation nor assuming any obligation to upd ...