BRIDGEWATER - Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ('Amneal' or the 'Company') announced its results today for the first quarter ended March 31, 2024.
'We are extremely pleased with our outstanding start to the year, as Amneal generated record levels of revenues in the first quarter. For the first time, all three segments across our diversified business produced double-digit top-line growth in the same quarter. With perpetual and rising demand for medicines and exacerbated by chronic supply shortages in the U.S. pharmaceutical industry, Amneal is part of the solution. As we become larger, we provide even more patients with access to high-quality, affordable, and essential medicines as we create value for all our stakeholders,' said Chirag and Chintu Patel, Co-Chief Executive Officers.
First Quarter 2024 Results
Net revenue in the first quarter of 2024 was $659 million, an increase of 18% compared to $558 million in the first quarter of 2023. Generics revenues increased 14% due to strong performance in complex generics, our oncology biosimilars and new launches. Specialty revenues increased 15% driven by promoted products in Neurology and Endocrinology. AvKARE revenues increased 33% driven by continued expansion across its channels due to new products.
Net loss attributable to Amneal Pharmaceuticals, Inc. was $92 million in the first quarter of 2024 compared to $7 million in the first quarter of 2023, and included a pre-tax charge of $94 million for settlement in principle on a nationwide opioids settlement.
Adjusted EBITDA in the first quarter of 2024 was $152 million, an increase of 31% compared to the first quarter of 2023, reflective of strong revenue performance and higher gross margins.
Diluted loss per share in the first quarter of 2024 was $0.30 compared to $0.05 for the first quarter of 2023 due to the aforementioned factors. Adjusted diluted earnings per share in the first quarter of 2024 was $0.14 compared to $0.12 for the first quarter of 2023.
Settlement in Principle on a Nationwide Opioids Settlement
Amneal has reached a settlement in principle on the primary financial terms, with no admission of wrongdoing, for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the Company by states, counties, municipalities, and Native American Tribal Nations across the United States. The settlement in principle resolves substantially all opioids litigation and is subject to the negotiation and execution of a definitive settlement agreement between the parties. The settlement would be payable over ten years. Under the settlement, the Company would agree to pay $92.5 million in cash and provide $180.0 million in naloxone nasal spray (valued at $125 per two-pack) to help treat opioid overdoses. In lieu of receiving product, the settling parties can opt to receive 25% of the product value (up to $45.0 million) in cash during the last four years of the ten-year payment term.
In the first quarter of 2024, the Company recorded a charge of $94 million in the consolidated statement of operations based on full participation in the potential settlement, which reflects the value of the cash payments and the supply of naloxone nasal spray over the ten-year period. The settlement in principle is contingent upon a sufficient number of settling parties electing to opt into the final definitive agreement. We remain committed to helping those impacted by the opioid crisis by enhancing access to naloxone nasal spray, which is an emergency treatment for opioid overdose and helps save lives.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as 'plans,' 'expects,' 'will,' 'anticipates,' 'estimates,' and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.
Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant and the high concentration of ownership of our Class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with the Securities and Exchange Commission, including under Item 1A, 'Risk Factors' in the Company's most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
Contact:
Anthony DiMeo
Email: anthony.dimeo@amneal.com
AMNEAL PHARMACEUTICALS, INC. 
