ANI Pharmaceuticals (ANIP) came out with quarterly earnings of $1.02 per share, beating the Zacks Consensus Estimate of $0.93 per share. This compares to earnings of $1.28 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 9.68%. A quarter ago, it was expected that this drugmaker would post earnings of $0.98 per share when it actually produced earnings of $1.21, delivering a surprise of 23.47%.Over the last four quarters, the com ...

[PART I — FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%94FINANCIAL%20INFORMATION) This section presents the unaudited condensed consolidated financial statements and management's discussion and analysis for ANI Pharmaceuticals, Inc [Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, income statements, and cash flows, along with detailed notes [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This subsection contains the core unaudited financial tables for the period, including balance sheets, statements of operations, and cash flows Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Total Assets** | **$920,753** | **$904,422** | | Cash and cash equivalents | $240,110 | $221,121 | | Inventories | $125,448 | $111,196 | | Intangible assets, net | $183,078 | $209,009 | | **Total Liabilities** | **$440,143** | **$446,823** | | Non-current debt, net | $284,394 | $284,819 | | **Total Stockholders' Equity** | **$455,760** | **$432,749** | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | **Net Revenues** | **$138,040** | **$116,547** | **$275,470** | **$223,333** | | Operating Income | $5,169 | $12,402 | $25,481 | $22,297 | | **Net (Loss) Income** | **($2,287)** | **$6,245** | **$15,920** | **$7,684** | | Diluted (Loss) Income Per Share | ($0.14) | $0.29 | $0.70 | $0.36 | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net Cash Provided by Operating Activities | $35,683 | $42,050 | | Net Cash Provided by (Used in) Investing Activities | $4,484 | ($9,179) | | Net Cash (Used in) Provided by Financing Activities | ($21,178) | $75,602 | | **Net Change in Cash** | **$18,989** | **$108,473** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide detailed explanations of accounting policies and specific line items, covering the Alimera merger, restructuring, debt, and legal contingencies - On June 21, 2024, the company entered into an agreement to acquire Alimera Sciences, Inc. for **$5.50 per share in cash** plus a contingent value right (CVR)[52](index=52&type=chunk)[53](index=53&type=chunk) - The Alimera transaction will be financed with **$280.0 million in committed debt**, incurring approximately **$3.5 million in transaction costs** in Q2 2024[57](index=57&type=chunk) - The company sold its Oakville, Ontario property on March 28, 2024, for approximately **$14.2 million**, resulting in a gain of approximately **$5.3 million**[61](index=61&type=chunk) Revenue by Segment (in thousands) | Segment | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Generics, Established Brands, and Other | $88,847 | $189,340 | | Rare Disease | $49,193 | $86,130 | | **Total Net Revenues** | **$138,040** | **$275,470** | - As of June 30, 2024, the company had **$292.5 million in principal outstanding** on its Term Facility with an interest rate of **11.44%**[64](index=64&type=chunk) - The **$40.0 million Revolving Facility** remained undrawn as of June 30, 2024[66](index=66&type=chunk) - The company is involved in several legal proceedings, including a royalty dispute with CG Oncology, patent litigation regarding a pitolisant hydrochloride drug product, and various ranitidine-related lawsuits[128](index=128&type=chunk)[130](index=130&type=chunk)[132](index=132&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial condition and results of operations, covering strategy, recent developments, operating results, and liquidity [Executive Overview and Strategy](index=37&type=section&id=Executive%20Overview%20and%20Strategy) Management outlines the company's strategy, centered on scaling the Rare Disease platform and strengthening the Generics and Established Brands segment - The company's core strategy is to deliver sustainable growth by scaling its Rare Disease business, led by Cortrophin Gel, and strengthening its Generics business through enhanced development and focus on niche opportunities[165](index=165&type=chunk)[166](index=166&type=chunk) - The pending acquisition of Alimera is a key strategic move intended to strengthen the Rare Disease business and expand the company's footprint internationally into Europe, Asia, and the Middle East[167](index=167&type=chunk) - The company continues to invest in its Rare Disease platform to support growth in new areas like pulmonology, ophthalmology, and gout for its ACTH products[168](index=168&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) This subsection provides a detailed comparative analysis of financial performance, breaking down changes in revenues, costs, and expenses Q2 2024 vs. Q2 2023 Revenue Performance (in thousands) | Segment | Q2 2024 Revenue | Q2 2023 Revenue | % Change | | :--- | :--- | :--- | :--- | | Generic pharmaceutical products | $73,964 | $63,317 | 16.8% | | Established brands, royalties, etc. | $14,883 | $28,926 | (48.5)% | | Rare disease pharmaceutical products | $49,193 | $24,304 | 102.4% | | **Total Net Revenues** | **$138,040** | **$116,547** | **18.4%** | - The **102.4% increase in Rare Disease revenue** was driven by increased volume of Cortrophin Gel in its third year of launch[193](index=193&type=chunk) - Selling, general, and administrative (SG&A) expenses increased by **36.3% to $52.8 million** in Q2 2024, driven by continued investment in the Rare Disease segment, legal expenses, and costs related to the pending Alimera acquisition[197](index=197&type=chunk) - For the six months ended June 30, 2024, net income was **$15.9 million**, a significant increase from **$7.7 million** in the prior year period, boosted by a **$5.3 million gain** on the sale of the Oakville property and a **$6.9 million unrealized gain** on an equity investment[15](index=15&type=chunk)[216](index=216&type=chunk)[218](index=218&type=chunk) [Liquidity and Capital Resources](index=49&type=section&id=Liquidity%20and%20Capital%20Resources) The company details its sources of liquidity, including cash from operations and credit facilities, and analyzes cash flow activities - As of June 30, 2024, the company had **$240.1 million in cash and cash equivalents** and **$40.0 million available** under its Revolving Facility[12](index=12&type=chunk)[224](index=224&type=chunk) - The company has secured a commitment for **$280.0 million in debt financing** to fund the pending acquisition of Alimera[225](index=225&type=chunk) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Operating Activities | $35,683 | $42,050 | | Investing Activities | $4,484 | ($9,179) | | Financing Activities | ($21,178) | $75,602 | - Key cash outflows in H1 2024 included a **$12.5 million contingent consideration payment** related to the Novitium acquisition and **$10.0 million for treasury stock purchases** for restricted stock vests[232](index=232&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=50&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states no material changes in its exposure to market risks, including interest rate, equity, and foreign currency exchange rate risks - There have been no material changes in the company's exposure to market risks, including interest rate, equity, and foreign currency exchange rate risk, since the end of the 2023 fiscal year[234](index=234&type=chunk) [Controls and Procedures](index=50&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2024, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2024[236](index=236&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[237](index=237&type=chunk) [PART II — OTHER INFORMATION](index=51&type=section&id=PART%20II%20%E2%80%94OTHER%20INFORMATION) This part covers legal proceedings, new risk factors related to the Alimera acquisition, equity security sales, and other miscellaneous items [Legal Proceedings](index=51&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference legal proceedings detailed in Note 13, covering commercial, patent, and ranitidine-related litigation - This item refers to Note 13, Commitments and Contingencies, for a full description of the company's ongoing legal matters[238](index=238&type=chunk) [Risk Factors](index=51&type=section&id=Item%201A.%20Risk%20Factors) This section introduces new significant risk factors related to the pending Alimera acquisition, including merger completion, debt, international operations, and supply chain - The pending merger with Alimera is subject to conditions beyond the company's control, and failure to complete it could have a material adverse effect on the business and stock price[240](index=240&type=chunk) - The company will incur substantial debt (**$280.0 million committed**) to finance the Alimera acquisition, which could impact future cash flow and operational flexibility[251](index=251&type=chunk) - The acquisition will materially increase international operations, exposing the company to new risks related to foreign regulations, currency exchange, tax laws, and supply chain complexities[256](index=256&type=chunk)[258](index=258&type=chunk) - Post-merger, the company will have increased reliance on single-source third-party manufacturers for Alimera's products, with one key supplier for YUTIQ receiving an FDA warning letter in July 2024, potentially affecting supply[265](index=265&type=chunk)[266](index=266&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=56&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities and discloses share repurchases from employees for tax withholding obligations - There were no sales of unregistered securities during the quarter[269](index=269&type=chunk) Issuer Purchases of Equity Securities (Q2 2024) | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April 2024 | 13,259 | $66.92 | | May 2024 | 5,816 | $65.02 | | June 2024 | 553 | $62.62 | | **Total** | **19,628** | **$66.23** | - All shares purchased were transferred from employees to satisfy tax withholding obligations on vested restricted stock awards and were not part of a formal repurchase plan[270](index=270&type=chunk) [Other Items (3, 4, 5, 6)](index=56&type=section&id=Other%20Items%20(3,%204,%205,%206)) This section confirms no defaults on senior securities, non-applicability of mine safety disclosures, no Rule 10b5-1 trading plan changes, and references exhibits - Item 3: No defaults upon senior securities[271](index=271&type=chunk) - Item 4: Mine Safety Disclosures are not applicable[272](index=272&type=chunk) - Item 5: No directors or executive officers adopted or terminated Rule 10b5-1 trading plans during the quarter[271](index=271&type=chunk) - Item 6: A list of exhibits filed with the Form 10-Q is provided[272](index=272&type=chunk)[273](index=273&type=chunk)

Exhibit 99.1 FOR IMMEDIATE RELEASE ANI Pharmaceuticals Reports Second Quarter 2024 Financial Results and Raises 2024 Guidance • Generated record quarterly net revenues of $138.0 million, representing year-over-year growth of 18.4%, and record Rare Disease net revenues of $49.2 million, an increase of 102.4% yearover-year • Delivered adjusted non-GAAP EBITDA of $33.2 million, and adjusted non-GAAP diluted earnings per share of $1.02 • Net loss available to common shareholders of $(2.7) million and diluted GA ...

Generated record quarterly net revenues of $138.0 million, representing year-over-year growth of 18.4%, and record Rare Disease net revenues of $49.2 million, an increase of 102.4% year-over-yearDelivered adjusted non-GAAP EBITDA of $33.2 million, and adjusted non-GAAP diluted earnings per share of $1.02Net loss available to common shareholders of $(2.7) million and diluted GAAP loss per share of $(0.14)On track to close acquisition of Alimera Sciences, Inc. in the third quarter of 2024, adding two durable ...

Generated record quarterly net revenues of $138.0 million, representing year-over-year growth of 18.4%, and record Rare Disease net revenues of $49.2 million, an increase of 102.4% year-over-yearDelivered adjusted non-GAAP EBITDA of $33.2 million, and adjusted non-GAAP diluted earnings per share of $1.02Net loss available to common shareholders of $(2.7) million and diluted GAAP loss per share of $(0.14)On track to close acquisition of Alimera Sciences, Inc. in the third quarter of 2024, adding two durable ...

Fokusiert/iStock via Getty ImagesAni Pharmaceuticals (NASDAQ:ANIP) had not provided any details on their three 505(b)(2) NDA submissions currently being reviewed by the FDA. Therefore, analysts have excluded their revenue potential in assessing ANIP’s growth outlook. On ANIP has yet to announce that on July 29, 2024 the FDA approved Tezruly as the first oral solution of terazosin. Tezruly's related patent expires February 1, 2041. Based on ANIP’s SEC filings, patent applications and clinical trial infor ...

PRINCETON, N.J., July 15, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Powder. ANI's L-Glutamine Oral Powder is the generic version of the reference listed drug (RLD) Endari®. "The approval and launch of L-Glutamine Oral Powder, the first AA-rated approved generic to Endari®, continues to ...

PRINCETON, N.J., July 02, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) and launched Naproxen Delayed-Release Tablets, USP. ANI's Naproxen Delayed-Release Tablets is the generic version of the reference listed drug (RLD) EC-Naprosyn®. "We are pleased to announce the first cycle FDA approval and commercialization of Naproxen Delayed-Release ...

PRINCETON, N.J., July 02, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) and launched Naproxen Delayed-Release Tablets, USP. ANI’s Naproxen Delayed-Release Tablets is the generic version of the reference listed drug (RLD) EC-Naprosyn®. "We are pleased to announce the first cycle FDA approval and commercialization of Naproxen Delayed-Release ...

PRINCETON, N.J., June 25, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that its Chief Executive Officer, Nikhil Lalwani, has been named an Ernst & Young LLP (EY US) Entrepreneur Of The Year® 2024 New Jersey Award winner. Entrepreneur Of The Year is the preeminent competitive awards program for entrepreneurs and leaders of high-growth companies. Mr. Lalwani was selected by an independent judging panel made up of previous award winners, leading CEOs, a ...