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 ...

Core Viewpoint - ANI Pharmaceuticals is well-positioned to continue its earnings-beat streak in upcoming reports, having surpassed earnings estimates consistently in recent quarters [1][2]. Earnings Performance - ANI Pharmaceuticals has topped earnings estimates by an average of 16.57% over the last two quarters [1]. - In the last reported quarter, ANI achieved earnings of $1.02 per share, exceeding the Zacks Consensus Estimate of $0.93 per share by 9.68% [1]. - For the previous quarter, ANI's actual earnings were $1.21 per share against an expected $0.98 per share, resulting in a surprise of 23.47% [1]. Earnings Estimates and Predictions - Estimates for ANI have been trending higher due to its history of earnings surprises [2]. - The stock has a positive Zacks Earnings ESP of +2.50%, indicating bullish sentiment among analysts regarding its near-term earnings potential [3]. - The combination of a positive Earnings ESP and a Zacks Rank 1 (Strong Buy) suggests a high likelihood of another earnings beat [3]. Importance of Earnings ESP - The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate, reflecting the latest analyst revisions [3]. - A positive Earnings ESP enhances the predictive power of potential earnings beats, while a negative value does not necessarily indicate an earnings miss [3][4]. - Utilizing the Earnings ESP Filter can help identify stocks with the best potential for success before earnings reports [4].

Piper Sandler has initiated coverage on ANI Pharmaceuticals ANIP, an integrated specialty pharmaceutical firm that develops and markets branded and generic medicines.The analyst notes that ANI’s business model has significantly transformed, shifting from a primary emphasis on generics to a new focus on integrating high-margin brand assets aimed at rare diseases. Cortrophin Gel (adrenocorticotropic hormone (ACTH)), the company’s lead asset, has been the centerpiece of that evolution.Cortrophin gel sales more ...

Biotech Forum Discussion - The Biotech Forum has been focused on lucrative buy-write or covered call opportunities on selected biotech stocks over the past several months [1] - The forum offers real-time trading ideas and insights from seasoned biotech investors [1] ANI Pharmaceuticals Spotlight - ANI Pharmaceuticals Inc (NASDAQ: ANIP) is highlighted as a small but growing biopharma company [1] - The equity is considered one of the few reasonable growth at a reasonable price (GARP) stocks in the biotech sector [1] The Biotech Forum Services - The Biotech Forum provides a model portfolio featuring 12-20 high upside biotech stocks [1] - The forum offers live chat for discussing trade ideas, weekly research, and option trades [1] - Market commentary and portfolio updates are provided every weekend [1]