For full year 2024, the Company expects total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS to be at or above the guidance ranges provided on November 8, 2024Rare Disease Segment performed in line with expectations, with Purified Cortrophin Gel net revenues of $197.8 million to $198.4 million for the full year 2024 and ILUVIEN and YUTIQ net revenues of $30.4 million to $31.0 million for the post-acquisition period from September 16, 2024 to December 31, 2024, based on preliminary ...

PRINCETON, N.J., Dec. 30, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced that Nikhil Lalwani, President and Chief Executive Officer; Stephen Carey, Chief Financial Officer; and Dr. Mary Pao, Chief Medical Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, at 2:15pm PST/5:15pm EST, in San Francisco. The live and archived webcast will be accessible from the Company’s website at www.anipharmaceutic ...

Core Viewpoint - ANI Pharmaceuticals (ANIP) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive outlook for its earnings estimates, which is expected to lead to increased buying pressure and a rise in stock price [1][2]. Earnings Estimates and Rating Upgrade - The upward trend in earnings estimates for ANI has resulted in a 7.9% increase in the Zacks Consensus Estimate over the past three months, reflecting an improvement in the company's underlying business [5][3]. - The Zacks Rank system, which categorizes stocks based on earnings estimates, has a strong historical performance, with Zacks Rank 1 stocks averaging a +25% annual return since 1988 [4]. Future Earnings Potential - ANI is projected to earn $5.02 per share for the fiscal year ending December 2024, representing a year-over-year increase of 6.6% [10]. Institutional Investor Influence - The relationship between earnings estimate revisions and stock price movements is significant, as institutional investors often adjust their valuations based on these estimates, leading to corresponding buying or selling actions [8][9]. Zacks Rating System - The Zacks rating system maintains a balanced distribution of 'buy' and 'sell' ratings, with only the top 5% of stocks receiving a 'Strong Buy' rating, indicating that ANI's upgrade places it in the top 20% of Zacks-covered stocks based on estimate revisions [11][12].

PRINCETON, N.J., Nov. 26, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced that Nikhil Lalwani, President and Chief Executive Officer, and Stephen Carey, Chief Financial Officer, will host a fireside chat at the 36th Annual Piper Sandler Healthcare Conference on Wednesday, December 4, 2024 at 3pm EST in NYC. The live and archived webcast will be accessible from the Company’s website at www.anipharmaceuticals.com, under the Investors section under Eve ...

ANI Pharmaceuticals (ANIP) closed the last trading session at $58.64, gaining 1.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $77 indicates a 31.3% upside potential. The mean estimate comprises five short-term price targets with a standard deviation of $12.39. While the lowest estimate of $62 indicates a 5.7% increase from the current price level, the most optimistic analyst e ...

Core Viewpoint - ANI Pharmaceuticals (ANIP) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the importance of earnings estimate revisions, which are strongly correlated with near-term stock price movements [4][6]. - For the fiscal year ending December 2024, ANI is projected to earn $5.02 per share, reflecting a 6.6% increase from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for ANI has risen by 10.5%, indicating a positive trend in earnings expectations [8]. Institutional Investor Influence - Institutional investors often base their valuation models on earnings estimates, leading to significant buying or selling actions that affect stock prices [4][5]. - The upgrade for ANI suggests an improvement in the company's underlying business, which is likely to attract investor interest and drive the stock price higher [5]. Zacks Rank System - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - ANI's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [11].

Financial Performance - Generated record quarterly net revenues of $148.3 million, representing year-over-year growth of 12.5%[1] - Purified Cortrophin® Gel net revenues reached $52.6 million, an increase of 76.8% year-over-year[1] - Adjusted non-GAAP net income for Q3 2024 was $148.3 million, compared to $131.8 million in Q3 2023, representing a year-over-year increase of 12.5%[41] - Net revenues for the three months ended September 30, 2024, were $148,332 thousand, up from $131,829 thousand in 2023, reflecting an increase of approximately 12.5%[43] - Adjusted non-GAAP EBITDA for Q3 2024 was $35.1 million, a decrease of 3.8% compared to the same period in 2023[14] - Adjusted non-GAAP EBITDA for the three months ended September 30, 2024, was $35,104 thousand, slightly down from $36,484 thousand in 2023[44] Expenses and Losses - Selling, general, and administrative expenses increased 88.2% to $79.1 million, primarily due to increased employment-related costs and acquisition-related expenses[12] - Total operating expenses for Q3 2024 were $168.9 million, up from $113.9 million in Q3 2023, reflecting a significant increase of 48.3%[41] - Research and development expenses decreased to $10.1 million in Q3 2024 from $11.1 million in Q3 2023, a decline of 9.0%[41] - The net loss for Q3 2024 was $24.2 million, compared to a net income of $9.9 million in Q3 2023, indicating a significant shift in profitability[41] - Basic and diluted loss per share for Q3 2024 was $(1.27), compared to earnings of $0.46 per share in Q3 2023[41] - The company incurred M&A transaction and integration expenses of $9,945 thousand for the three months ended September 30, 2024, compared to $165 thousand in 2023, indicating a significant increase in costs associated with mergers and acquisitions[44] Guidance and Future Expectations - Increased 2024 guidance with expected net revenues of $594 million to $602 million, up from previous guidance of $540 million to $560 million[17] - Cortrophin Gel net revenues guidance for 2024 is $196 million to $200 million, representing year-over-year growth of 75% to 78%[17] - The company expects to capture approximately $10 million of identified cost synergies from the Alimera acquisition in 2025[5] Acquisitions and Business Expansion - Completed the acquisition of Alimera Sciences on September 16, 2024, adding ILUVIEN® and YUTIQ® to the Rare Disease portfolio[1] - The company is focused on expanding its Rare Disease business, which includes novel products in various therapeutic areas[36] Cash and Assets - As of September 30, 2024, the company had $145.0 million in unrestricted cash and cash equivalents[15] - As of September 30, 2024, total assets increased to $1,287,377 thousand from $904,422 thousand as of December 31, 2023, representing a growth of approximately 42.4%[42] - The company’s cash and cash equivalents decreased to $144,982 thousand as of September 30, 2024, from $221,121 thousand as of December 31, 2023, a decline of approximately 34.3%[42] Liabilities and Equity - Total current liabilities rose to $189,933 thousand as of September 30, 2024, compared to $145,477 thousand as of December 31, 2023, indicating an increase of about 30.5%[42] - Non-current liabilities increased to $312,918 thousand as of September 30, 2024, from $284,819 thousand as of December 31, 2023, reflecting a growth of approximately 9.9%[42] - The company reported a total stockholders' equity of $405,948 thousand as of September 30, 2024, down from $432,749 thousand as of December 31, 2023, a decrease of about 6.2%[42] Other Financial Metrics - Total depreciation and amortization expenses for the three months ended September 30, 2024, were $15.748 million, slightly up from $15.207 million in the same period of 2023[47] - Stock-based compensation for the three months ended September 30, 2024, was $7.484 million, compared to $5.444 million in the same period of 2023[47] - The diluted weighted-average shares outstanding increased to 19.404 million for the three months ended September 30, 2024, from 19.125 million in the same period of 2023[47] Risks and Challenges - Risks include the ability to achieve commercial success with Cortrophin Gel and the impact of supply chain disruptions on production[39] - The impact of Canada operations included revenues and expenses that will not recur after the closure of operations, which was completed as of March 31, 2023[47] - The company recorded a loss on extinguishment of debt of $7.468 million for the three months ended September 30, 2024[47] - The unrealized gain on investment in equity securities for the three months ended September 30, 2024, was a loss of $1.355 million, with no comparable figure in the same period of 2023[47]

Financial Performance and Key Metrics - The company reported total revenues of $148.3 million for Q3 2024, an increase of 13% compared to Q3 2023, driven by strong demand for Cortrophin Gel and growth in generics [12][28] - Adjusted non-GAAP EBITDA was $35.1 million, while adjusted non-GAAP EPS was $1.34, compared to $1.27 in the prior year [36] - Cortrophin Gel generated $52.6 million in revenues, up 77% year-over-year, with the highest number of new patient starts and unique prescribers since its launch [13][28] Business Line Performance - The generics business achieved revenues of $78.2 million, an increase of 11% over the prior year, reflecting strength in the base business and contributions from new product launches [14][31] - Revenues from established brands and other segments were $13.7 million, a decrease of 57% year-over-year, aligning with expectations [31] Market Data and Key Metrics - The overall ACTH category is expected to deliver more than 20% year-over-year growth in 2024, with Cortrophin Gel on a strong multi-year growth trajectory [14][50] - The company expects to capture $10 million in synergies from the Alimera acquisition by 2025, contributing to adjusted non-GAAP EBITDA of $35 million to $38 million [11][39] Company Strategy and Industry Competition - The acquisition of Alimera is seen as transformative for the Rare Disease business, with expectations of substantial shareholder value creation [11][39] - The company is focused on integrating the Alimera products and leveraging its expanded sales force to drive growth in ophthalmology and other specialties [9][27] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Cortrophin Gel and the overall Rare Disease segment, anticipating it to be the largest business unit and growth driver in 2025 [27][66] - The company raised its full-year 2024 guidance, reflecting continued strength in Cortrophin Gel and contributions from ILUVIEN and YUTIQ [39][40] Other Important Information - The company ended the quarter with $145 million in unrestricted cash and $641.3 million in outstanding debt, with gross leverage at approximately 3.8 times [37] - Non-GAAP gross margin was reported at 60%, a decrease of approximately 3.9 points from the prior year, primarily due to an unfavorable product mix [33] Q&A Session Summary Question: Can you talk about the payer landscape for Cortrophin Gel? - Management noted that the payer landscape is evolving, with increased affordability for seniors expected to improve patient access [48] Question: What is the mix of growth from existing versus new prescribers for Cortrophin? - Growth has come from both existing prescribers moving away from competitors and new prescribers unique to Cortrophin Gel [49][50] Question: What does the cadence of new launches for generics look like for 2025? - The company expects to continue a strong cadence of new launches, projecting growth in the high-single-digits to low double-digits for the generics business [51] Question: What is the expected quarterly run rate for ILUVIEN and YUTIQ going into next year? - Management indicated that the Q4 guidance reflects a transition period, with expectations for growth in 2025 [56] Question: How is the combined sales team impacting Cortrophin in ophthalmology? - Early signs are positive, and management remains confident in growth from the combined sales force [62] Question: What lessons were learned from the Alimera acquisition? - The company emphasized the importance of strategic alignment and addressing challenges effectively during acquisitions [68][70]

ANI Pharmaceuticals (ANIP) reported $148.33 million in revenue for the quarter ended September 2024, representing a year-over-year increase of 12.5%. EPS of $1.34 for the same period compares to $1.27 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $143.97 million, representing a surprise of +3.03%. The company delivered an EPS surprise of +22.94%, with the consensus EPS estimate being $1.09.While investors closely watch year-over-year changes in headline numbers -- revenue and e ...

Company Performance - ANI Pharmaceuticals reported quarterly earnings of $1.34 per share, exceeding the Zacks Consensus Estimate of $1.09 per share, and showing an increase from $1.27 per share a year ago, representing an earnings surprise of 22.94% [1] - The company achieved revenues of $148.33 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 3.03%, and up from $131.83 million year-over-year [2] - Over the last four quarters, ANI has consistently surpassed consensus EPS and revenue estimates [2] Stock Outlook - The immediate price movement of ANI's stock will largely depend on management's commentary during the earnings call and future earnings expectations [3] - Since the beginning of the year, ANI shares have increased by approximately 5.9%, while the S&P 500 has gained 25.2% [3] - The current consensus EPS estimate for the upcoming quarter is $1.39 on revenues of $168.84 million, and for the current fiscal year, it is $4.71 on revenues of $588.24 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which ANI belongs, is currently ranked in the top 35% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5] - The performance of ANI's stock may also be influenced by the overall industry outlook [8]