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 ...

ANI Pharmaceuticals (ANIP) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Individual inve ...

Exhibit 99.1 FOR IMMEDIATE RELEASE ANI Pharmaceuticals Reports Record Third Quarter 2024 Financial Results and Raises 2024 Guidance • Generated record quarterly net revenues of $148.3 million, representing year-over-year growth of 12.5%, and record Purified Cortrophin® Gel net revenues of $52.6 million, an increase of 76.8% year-over-year • Net loss of $(24.2) million and adjusted non-GAAP EBITDA of $35.1 million • Diluted GAAP loss per share of $(1.27) and adjusted non-GAAP diluted earnings per share of $1 ...

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]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 o TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | |----------------------------|---------------------|------------------------------------------------------| | Title of each class: | Trading Symbol(s) | Name of each exchang ...

Core Insights - ANI Pharmaceuticals reported record quarterly net revenues of $148.3 million, reflecting a year-over-year growth of 12.5%, with Purified Cortrophin® Gel net revenues reaching $52.6 million, an increase of 76.8% year-over-year [1][9] - The company completed the acquisition of Alimera Sciences, enhancing its Rare Disease portfolio with two commercial assets, ILUVIEN® and YUTIQ®, which are expected to drive significant growth [1][6] - ANI Pharmaceuticals raised its 2024 guidance, projecting net revenues between $594 million and $602 million, adjusted non-GAAP EBITDA of $149 million to $153 million, and adjusted non-GAAP earnings per share of $4.90 to $5.05 [1][16] Financial Performance - The net loss for the third quarter was $(24.2) million, with an adjusted non-GAAP EBITDA of $35.1 million, a decrease of 3.8% compared to the same quarter in 2023 [1][14] - Diluted GAAP loss per share was $(1.27), while adjusted non-GAAP diluted earnings per share stood at $1.34, compared to $1.27 in the prior year [1][13] - Gross margin on a GAAP basis decreased from 63.5% to 57.5%, primarily due to a shift in revenue mix [11] Business Segments - The Rare Disease segment generated revenues of $56.4 million, an increase of 89.8% year-over-year, driven by strong performance of Cortrophin Gel [4][9] - The Generics business achieved a year-over-year growth of 10.8%, attributed to robust R&D capabilities and operational excellence [5][10] - The acquisition of Alimera Sciences contributed $3.9 million in revenues for the last two weeks of the quarter, with expected revenues of $30 million to $32 million for the remainder of the year [6][7] Capital Structure and Guidance - ANI implemented a new capital structure expected to reduce annual interest expenses by approximately $39 million [1][3] - The company anticipates total adjusted non-GAAP gross margin to be at the high end of the previously communicated range of 61% to 62% for 2024 [16] - The updated guidance reflects a growth of 22% to 24% compared to 2023 actual results [16]

Group 1 - ANI Pharmaceuticals, Inc. will present at two upcoming investor conferences: the Guggenheim Inaugural Healthcare Innovation Conference on November 13, 2024, and the Jefferies London Healthcare Conference on November 20, 2024 [1] - The presentations will be made by Nikhil Lalwani, President and CEO, and Stephen Carey, CFO [1] - Live and archived webcasts of the presentations will be available on the company's website for 90 days [1] Group 2 - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics [2] - The company aims for sustainable growth through its Rare Disease business, Generics business, and Established Brands business [2] - ANI Pharmaceuticals markets products in various therapeutic areas including ophthalmology, rheumatology, nephrology, neurology, and pulmonology [2]