[PART I — FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%94FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) The unaudited statements for Q1 2024 show significant growth in net revenues and net income compared to the prior year Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Total Assets** | **$914,524** | **$904,422** | | Cash and cash equivalents | $228,597 | $221,121 | | Accounts receivable, net | $172,418 | $162,079 | | Inventories | $113,837 | $111,196 | | Intangible assets, net | $196,044 | $209,009 | | **Total Liabilities** | **$437,711** | **$446,823** | | Non-current debt, net | $284,607 | $284,819 | | **Total Stockholders' Equity** | **$451,963** | **$432,749** | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share amounts) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | **Net Revenues** | **$137,430** | **$106,786** | | Operating Income | $20,312 | $9,895 | | **Net Income** | **$18,207** | **$1,439** | | Net Income Available to Common Shareholders | $17,801 | $1,033 | | **Diluted Income Per Share** | **$0.82** | **$0.06** | [Note 1. Business, Presentation, and Recent Accounting Pronouncements](index=10&type=section&id=Note%201.%20Business%2C%20Presentation%2C%20and%20Recent%20Accounting%20Pronouncements) The company is a diversified bio-pharmaceutical firm focused on Rare Disease and generics with U.S. manufacturing - The company's strategic focus is on scaling its **Rare Disease business**, strengthening its **generics portfolio**, and leveraging its **U.S.-based manufacturing capabilities**[26](index=26&type=chunk) - The Oakville, Ontario, Canada site was sold on March 28, 2024, for approximately **$14.2 million** as part of initiatives to capture operational synergies[26](index=26&type=chunk) [Note 2. Revenue Recognition and Related Allowances](index=13&type=section&id=Note%202.%20Revenue%20Recognition%20and%20Related%20Allowances) Revenue is primarily from pharmaceutical sales, with four customers accounting for 70% of net revenues in Q1 2024 Disaggregation of Revenue (in thousands) | Products and Services | March 31, 2024 | March 31, 2023 | | :--- | :--- | :--- | | Sales of generic pharmaceutical products | $70,217 | $63,713 | | Sales of established brand products, royalties, etc. | $30,276 | $26,743 | | Sales of rare disease pharmaceutical products | $36,937 | $16,330 | | **Total net revenues** | **$137,430** | **$106,786** | - In Q1 2024, four customers accounted for 34%, 13%, 10%, and 13% of net revenues, respectively, totaling **70% of net revenues**[49](index=49&type=chunk)[50](index=50&type=chunk) [Note 3. Restructuring](index=15&type=section&id=Note%203.%20Restructuring) The company sold its Oakville, Canada manufacturing plant in March 2024, resulting in a $5.3 million gain - The sale of the Oakville property was completed on March 28, 2024, generating a gain of approximately **$5.3 million**[54](index=54&type=chunk) [Note 4. Indebtedness](index=15&type=section&id=Note%204.%20Indebtedness) The company's total outstanding principal on its senior secured term loan was $293.3 million as of March 31, 2024 Term Facility Debt Summary (in thousands) | Component | March 31, 2024 | | :--- | :--- | | Non-current borrowing on debt | $290,250 | | Deferred financing costs | ($5,643) | | **Non-current debt, net** | **$284,607** | - The outstanding principal on the Term Facility was **$293.3 million** as of March 31, 2024, while the **$40.0 million** Revolving Facility was undrawn[58](index=58&type=chunk)[60](index=60&type=chunk) [Note 5. Derivative Financial Instrument and Hedging Activity](index=17&type=section&id=Note%205.%20Derivative%20Financial%20Instrument%20and%20Hedging%20Activity) An interest rate swap with a notional amount of $139.4 million is used to hedge against variable interest rate risk - The interest rate swap is designated as an effective cash flow hedge, with a notional amount of **$139.4 million** and a fair value asset of **$7.7 million** as of March 31, 2024[67](index=67&type=chunk) [Note 6. Earnings Per Share](index=18&type=section&id=Note%206.%20Earnings%20Per%20Share) Earnings per share increased significantly in Q1 2024, driven by higher net income Earnings Per Share Comparison | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Basic EPS | $0.84 | $0.06 | | Diluted EPS | $0.82 | $0.06 | [Note 8. Goodwill and Intangible Assets](index=19&type=section&id=Note%208.%20Goodwill%20and%20Intangible%20Assets) Net intangible assets totaled $196.0 million as of March 31, 2024, with no impairment charges recognized Intangible Assets Summary (in thousands) | Asset Type | Net Carrying Amount (Mar 31, 2024) | | :--- | :--- | | Acquired ANDAs | $103,079 | | NDAs and product rights | $54,215 | | Customer relationships | $16,305 | | In process research and development (IPR&D) | $19,800 | | **Total Intangible Assets, net** | **$196,044** | - Amortization expense for definite-lived intangibles was **$13.0 million** for the three months ended March 31, 2024, and no impairment losses were recognized[83](index=83&type=chunk) [Note 12. Commitments and Contingencies](index=25&type=section&id=Note%2012.%20Commitments%20and%20Contingencies) The company faces various legal proceedings and regulatory risks related to certain marketed products - Four products are marketed without approved NDAs or ANDAs, generating **$4.1 million** in net revenues in Q1 2024[114](index=114&type=chunk) - In March 2024, ANI initiated a civil action against CG Oncology, Inc. to enforce a **5% running royalty obligation** on worldwide net sales of cretostimogene[122](index=122&type=chunk) - The company is a defendant in ongoing **ranitidine-related litigation** in both federal and state courts[126](index=126&type=chunk)[127](index=127&type=chunk) [Note 13. Fair Value Disclosures](index=29&type=section&id=Note%2013.%20Fair%20Value%20Disclosures) Fair value measurements include an investment in CG Oncology valued at $9.7 million and contingent consideration of $11.6 million - The company holds 219,925 shares of CG Oncology (Nasdaq: CGON), which had a fair value of **$9.7 million** as of March 31, 2024[135](index=135&type=chunk) - The fair value of the contingent consideration liability from the Novitium acquisition decreased to **$11.6 million** from $24.0 million, primarily due to a **$12.5 million payment**[137](index=137&type=chunk)[140](index=140&type=chunk) [Note 15. Segment Reporting](index=32&type=section&id=Note%2015.%20Segment%20Reporting) The Rare Disease segment revenue grew 126% year-over-year, while the Generics segment also showed solid growth Segment Net Revenues (in thousands) | Segment | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Generics, Established Brands, and Other | $100,493 | $90,456 | | Rare Disease | $36,937 | $16,330 | | **Total net revenues** | **$137,430** | **$106,786** | Segment EBITDA (in thousands) | Segment | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Generics, Established Brands, and Other | $45,306 | $38,828 | | Rare Disease | $396 | ($1,251) | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion highlights a 28.7% revenue increase in Q1 2024, driven by strong segment performance - The company's growth strategy is focused on its **Rare Disease platform** and strengthening its **Generics segment** with niche opportunities[158](index=158&type=chunk)[161](index=161&type=chunk) - The sale of the Oakville, Ontario property was completed on March 28, 2024, resulting in net cash proceeds of approximately **$13.5 million** and a gain on sale of **$5.3 million**[165](index=165&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Net revenues increased 28.7% to $137.4 million in Q1 2024, with rare disease product revenues surging 126.2% Net Revenues Change by Segment (in thousands) | Segment | Q1 2024 | Q1 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Generic pharmaceutical products | $70,217 | $63,713 | $6,504 | 10.2% | | Established brand products, etc. | $30,276 | $26,743 | $3,533 | 13.2% | | Rare disease pharmaceutical products | $36,937 | $16,330 | $20,607 | 126.2% | | **Total net revenues** | **$137,430** | **$106,786** | **$30,644** | **28.7%** | - The increase in rare disease revenue was driven by **increased volume of Cortrophin Gel** in its third year of launch[176](index=176&type=chunk) - Selling, general, and administrative expenses increased by **$11.6 million (31.7%)** due to higher employment costs and investment in the Rare Disease segment[182](index=182&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintained a strong liquidity position with $228.6 million in cash and cash equivalents as of March 31, 2024 Summary of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Operating Activities | $18,269 | $21,424 | | Investing Activities | $8,933 | ($2,353) | | Financing Activities | ($19,726) | ($4,548) | - The company has **$40.0 million available** for borrowing under its revolving credit facility as of March 31, 2024[193](index=193&type=chunk)[194](index=194&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks remain interest rate, equity, and foreign currency exchange rate risk - The most significant market risks identified are **interest rate risk, equity risk, and foreign currency exchange rate risk**, with no material changes reported[203](index=203&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2024 - Based on an evaluation as of March 31, 2024, the principal executive and financial officers concluded that **disclosure controls and procedures were effective**[205](index=205&type=chunk) - **No material changes** in internal control over financial reporting occurred during the quarter[206](index=206&type=chunk) [PART II — OTHER INFORMATION](index=43&type=section&id=PART%20II%20%E2%80%94OTHER%20INFORMATION) [Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) Details regarding ongoing legal proceedings are provided in Note 12 of the financial statements - For details on legal proceedings, the report refers to **Note 12, Commitments and Contingencies**, in the financial statements[207](index=207&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors disclosed in the 2023 Annual Report on Form 10-K have occurred - The company directs investors to the Risk Factors section of its **2023 Annual Report on Form 10-K**, indicating no material changes[208](index=208&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company purchased 129,016 shares from employees to satisfy tax withholding obligations for vested stock awards Issuer Purchases of Equity Securities (Q1 2024) | Period | Total Number of Shares Purchased | | :--- | :--- | | January 2024 | 3,320 | | February 2024 | 49,066 | | March 2024 | 76,630 | | **Total** | **129,016** | - The shares purchased were acquired from employees to cover **minimum tax withholding obligations** and were not part of a publicly announced repurchase plan[211](index=211&type=chunk)

Generated record quarterly net revenues of $137.4 million, representing year-over-year growth of 28.7%, net income to common shareholders of $17.8 million, and GAAP diluted earnings per share of $0.82Delivered record adjusted non-GAAP EBITDA of $37.6 million, and adjusted non-GAAP diluted earnings per share of $1.21Rare Disease business delivered Q1 net revenues of $36.9 million, representing year-over-year growth of 126.2%Reiterated 2024 guidance of net revenues of $520 million to $542 million, adjusted no ...

Investors are always looking for stocks that are poised to beat at earnings season and ANI Pharmaceuticals, Inc. (ANIP) may be one such company. The firm has earnings coming up pretty soon, and events are shaping up quite nicely for their report.That is because ANI Pharmaceuticals is seeing favorable earnings estimate revision activity as of late, which is generally a precursor to an earnings beat. After all, analysts raising estimates right before earnings — with the most up-to-date information possible — ...

ANI Pharmaceuticals (ANIP) is slated to report first-quarter 2024 results on May 10, before the opening bell. Investors are advised to focus on the sales performance of the company’s core business segments — rare disease and generic business.The Zacks Consensus Estimate for the company’s earnings per share is currently pegged at 98 cents. The Zacks Consensus Estimate for total revenues is pinned at $125 million.Let's see how things might have shaped up for the upcoming quarterly release.Factors to ConsiderA ...

BAUDETTE, Minn., April 18, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its first quarter 2024 financial results on Friday, May 10, 2024, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, and Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, will host a conference call to discuss the results as follows: Date Friday, May 10, 2024 Time 8:30 a.m. ET Toll free ( ...

BAUDETTE, Minn., April 18, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its first quarter 2024 financial results on Friday, May 10, 2024, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, and Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, will host a conference call to discuss the results as follows: DateFriday, May 10, 2024  Time8:30 a.m. ET  Toll free ( ...

Have you been searching for a stock that might be well-positioned to maintain its earnings-beat streak in its upcoming report? It is worth considering ANI Pharmaceuticals (ANIP) , which belongs to the Zacks Medical - Biomedical and Genetics industry.This drugmaker has an established record of topping earnings estimates, especially when looking at the previous two reports. The company boasts an average surprise for the past two quarters of 46.05%.For the most recent quarter, ANI was expected to post earnings ...

BAUDETTE, Minn., April 09, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced the launch of Baclofen Oral Suspension, a generic version of the reference listed drug (RLD) Fleqsuvy®. "The launch of Baclofen Oral Suspension represents another entry for ANI into a rapidly growing limited competition market. We are proud of our ability to recognize the market need and provide our customers with the best suited packing configurations to match their requirements ...

Investors often turn to recommendations made by Wall Street analysts before making a Buy, Sell, or Hold decision about a stock. While media reports about rating changes by these brokerage-firm employed (or sell-side) analysts often affect a stock's price, do they really matter?Let's take a look at what these Wall Street heavyweights have to say about ANI Pharmaceuticals (ANIP) before we discuss the reliability of brokerage recommendations and how to use them to your advantage.ANI currently has an average br ...

BAUDETTE, Minn., April 04, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) https://www.anipharmaceuticals.com/ (NASDAQ:ANIP) is proud to support the Foundation for Sarcoidosis Research's (FSR) commitment to sarcoidosis patients and efforts to increase disease awareness during April's Sarcoidosis Awareness Month. During the month of April, members of the ANI organization are raising awareness of sarcoidosis by wearing "Say Sarcoidosis" pins offered through FSRs National Awareness Camp ...