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]

PART I — FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, with detailed notes on business, acquisitions, and debt for the reported periods [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a significant increase in total assets and liabilities from December 31, 2023, to September 30, 2024, primarily driven by the Alimera acquisition and related financing | Metric | Sep 30, 2024 (in thousands) | Dec 31, 2023 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Total Assets | $1,287,377 | $904,422 | $382,955 | | Total Liabilities | $856,579 | $446,823 | $409,756 | | Total Stockholders' Equity | $405,948 | $432,749 | $(26,801) | - **Intangible assets, net**, increased significantly from **$209,009 thousand** to **$569,825 thousand**, and **Goodwill** increased from **$28,221 thousand** to **$60,426 thousand**, largely due to the **Alimera acquisition**[9](index=9&type=chunk) - **Non-current convertible notes, net**, appeared at **$305,293 thousand** as of September 30, 2024, with no balance at December 31, 2023, reflecting **new financing**[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three and nine months ended September 30, 2024, the company reported a net loss, a significant shift from net income in the prior year periods, despite increased net revenues, primarily due to higher operating expenses and a loss on debt extinguishment | Metric | 3 Months Ended Sep 30, 2024 (in thousands) | 3 Months Ended Sep 30, 2023 (in thousands) | Change (in thousands) | % Change | | :-------------------------------------- | :----------------------------------------- | :----------------------------------------- | :-------------------- | :------- | | Net Revenues | $148,332 | $131,829 | $16,503 | 12.5% | | Operating (loss) income | $(20,519) | $17,948 | $(38,467) | -214.4% | | Net (Loss) Income | $(24,166) | $9,940 | $(34,106) | -343.1% | | Basic (Loss) Income Per Share | $(1.27) | $0.46 | $(1.73) | -376.1% | | Metric | 9 Months Ended Sep 30, 2024 (in thousands) | 9 Months Ended Sep 30, 2023 (in thousands) | Change (in thousands) | % Change | | :-------------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | :------- | | Net Revenues | $423,802 | $355,162 | $68,640 | 19.3% | | Operating (loss) income | $4,962 | $40,245 | $(35,283) | -87.7% | | Net (Loss) Income | $(8,246) | $17,624 | $(25,870) | -146.8% | | Basic (Loss) Income Per Share | $(0.49) | $0.84 | $(1.33) | -158.3% | - **Selling, general, and administrative expenses** increased significantly by **88.2%** for the three months and **53.5%** for the nine months ended September 30, 2024, compared to the prior year, largely due to **Alimera acquisition-related costs** and increased **Rare Disease sales and marketing**[11](index=11&type=chunk)[252](index=252&type=chunk)[270](index=270&type=chunk) - A **loss on extinguishment of debt** of **$7,468 thousand** was recognized for both the three and nine months ended September 30, 2024, due to the repayment of the **Truist Credit Facility**[11](index=11&type=chunk)[259](index=259&type=chunk)[279](index=279&type=chunk) [Condensed Consolidated Statements of Comprehensive (Loss) Income](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20(Loss)%20Income) The company reported a total comprehensive loss for both the three and nine months ended September 30, 2024, primarily driven by the net loss and a significant loss on interest rate swaps, contrasting with comprehensive income in the prior year | Metric | 3 Months Ended Sep 30, 2024 (in thousands) | 3 Months Ended Sep 30, 2023 (in thousands) | Change (in thousands) | | :-------------------------------------- | :----------------------------------------- | :----------------------------------------- | :-------------------- | | Net (Loss) Income | $(24,166) | $9,940 | $(34,106) | | Total other comprehensive (loss) income, net of tax | $(2,962) | $350 | $(3,312) | | Total comprehensive (loss) income, net of tax | $(27,128) | $10,290 | $(37,418) | - **Loss on interest rate swap** was **$(2,862) thousand** for the three months and **$(3,282) thousand** for the nine months ended September 30, 2024, compared to gains in the prior year[13](index=13&type=chunk) [Condensed Consolidated Statements of Changes in Mezzanine Equity and Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Mezzanine%20Equity%20and%20Stockholders'%20Equity) The statements reflect a decrease in total stockholders' equity from December 31, 2023, to September 30, 2024, primarily due to the net loss and other comprehensive loss, partially offset by stock-based compensation | Metric | Sep 30, 2024 (in thousands) | Dec 31, 2023 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Total Stockholders' Equity | $430,798 | $457,599 | $(26,801) | | Additional paid-in capital | $510,899 | $514,103 | $(3,204) | | Accumulated deficit | $(89,597) | $(80,132) | $(9,465) | | Accumulated other comprehensive income, net of tax | $5,366 | $8,857 | $(3,491) | - **Stock-based compensation expense** contributed **$22,283 thousand** to **additional paid-in capital** for the nine months ended September 30, 2024[16](index=16&type=chunk) - **Treasury stock purchases** for **restricted stock vests** amounted to **$(10,641) thousand** for the nine months ended September 30, 2024[16](index=16&type=chunk) - A **Capped Call Transaction**, net of tax, resulted in a **$(30,275) thousand** reduction in **additional paid-in capital** for the nine months ended September 30, 2024[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities decreased for the nine months ended September 30, 2024, compared to the prior year, while investing activities saw a significant increase in cash used due to the Alimera acquisition, and financing activities provided substantial cash through new debt and convertible notes | Metric | 9 Months Ended Sep 30, 2024 (in thousands) | 9 Months Ended Sep 30, 2023 (in thousands) | Change (in thousands) | | :--------------------------------------------------- | :----------------------------------------- | :----------------------------------------- | :-------------------- | | Net Cash and Cash Equivalents Provided by Operating Activities | $48,157 | $74,219 | $(26,062) | | Net Cash and Cash Equivalents Used in Investing Activities | $(394,038) | $(13,732) | $(380,306) | | Net Cash and Cash Equivalents Provided by Financing Activities | $269,852 | $79,357 | $190,495 | | Net Change in Cash, Cash Equivalents, and Restricted Cash | $(76,104) | $139,844 | $(215,948) | - **Acquisition of Alimera**, net of cash acquired, used **$(393,079) thousand** in investing activities[18](index=18&type=chunk) - **Proceeds from convertible notes** were **$316,250 thousand** and from **term loan** were **$325,000 thousand** in financing activities[18](index=18&type=chunk) - **Repayment on borrowings under credit agreement** was **$(292,500) thousand**, and **purchase of capped call transaction** was **$(40,575) thousand**[18](index=18&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=13&type=section

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]

Wall Street expects a year-over-year decline in earnings on higher revenues when ANI Pharmaceuticals (ANIP) reports results for the quarter ended September 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on November 8, 2024, might help the stock move higher if these key numbers are bett ...

PRINCETON, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ: ANIP) today announced that the Company will release its third quarter 2024 financial results on Friday, November 8, 2024, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, and Chris Mutz, Head of Rare Disease, will host a conference call to discuss the results as follows: Date Friday, Novem ...

Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, particularly for diseases with high unmet medical needs [2] - The company aims to achieve sustainable growth by scaling its Rare Disease business, enhancing its Generics business through improved research and development, and leveraging its U.S.-based manufacturing capabilities [2] Recent Developments - ANI Pharmaceuticals announced the launch of Estradiol Gel, 0.06%, following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) [1] - Estradiol Gel, 0.06% is the generic version of the reference listed drug EstroGel® Gel, 0.06% [1] - The U.S. annual sales for Estradiol Gel, 0.06% are approximately $16.7 million based on August 2024 moving annual total (MAT) IQVIA data [1]

PRINCETON, N.J., Oct. 24, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that the Company will present new pre-clinical data highlighting its membranous nephropathy (MN) research during two poster presentations at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego, CA, October 23-27. "We are excited to share our data with the ASN 2024 community. These data shed light of the potential role of melanocortin receptors in the underlying ...