Amneal Reports Fourth Quarter and Full Year 2021 Financial Results

‒ Q4 2021 Net Revenue of $537 million; GAAP Net Loss of $6 million; Diluted Loss per Share of $0.04 ‒
‒ Q4 2021 Adjusted Net Income of $54 million ⁽¹⁾, Adjusted EBITDA ⁽¹⁾ of $126 million; Adjusted Diluted EPS ⁽¹⁾ of $0.18 ‒

‒ Full Year Net Revenue of $2.1 billion; GAAP Net Income of $11 million; Diluted EPS of $0.07 ‒
‒ Full Year 2021 Adjusted Net Income ⁽¹⁾ of $258 million; Adjusted EBITDA ⁽¹⁾ of $538 million; Adjusted Diluted EPS ⁽¹⁾ of $0.85 ‒

‒ Provides 2022 Financial Guidance of $2.15 to $2.25 billion in net revenue and $540 to $560 million in adjusted EBITDA –

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) announced its results today for the fourth quarter and full year ended December 31, 2021.

“2021 was a transformational year for Amneal as we delivered strong financial results, including 18 percent adjusted EBITDA growth, and advanced our evolution into a diversified biopharmaceutical company. We continued to deepen our robust R&D pipeline and added compelling assets in key growth areas – including Injectables, Specialty and Biosimilars. We enter 2022 feeling great about our future growth prospects and well positioned as we focus on further diversifying and scaling in high-growth markets. We are proud of our team’s execution and confident in creating substantial value for all stakeholders,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

Net revenue in the fourth quarter of 2021 was $537 million, an increase of 5% compared to $510 million in the fourth quarter of 2020. The increase was driven by Generic new product launches and growth in our promoted Specialty products, including Rytary® and Unithroid®, partially offset by price erosion. Net loss attributable to Amneal Pharmaceuticals, Inc. was $6 million in the fourth quarter of 2021 compared to a net loss of $3 million in the fourth quarter of 2020. Adjusted EBITDA⁽¹⁾ in the fourth quarter of 2021 was $126 million, an increase of 18% compared to the fourth quarter of 2020, reflective of higher adjusted gross profit driven by higher revenues, reduced material costs and operating efficiencies, partially offset by higher expenses. Adjusted diluted EPS⁽¹⁾ in the fourth quarter of 2021 was $0.18, an increase of 29% from $0.14 in the fourth quarter of 2020, which reflects growth in adjusted EBITDA⁽¹⁾.

Net revenue for the year ended December 31, 2021 was $2,094 million, an increase of 5% compared to $1,993 million for the year ended December 31, 2020. The increase was driven by Generic new product launches, growth in our promoted Specialty products, including Rytary® and Unithroid®, and growth in our AvKARE segment, partially offset by price erosion. Net income attributable to Amneal Pharmaceuticals, Inc. was $11 million for the year ended December 31, 2021 compared to net income of $91 million for the year ended December 31, 2020, which included a discrete tax benefit of $110 million related to the CARES Act. Adjusted EBITDA⁽¹⁾ for the year ended December 31, 2021 was $538 million, an increase of 18% compared to the year ended December 31, 2020, reflective of adjusted gross margin improvements in all three segments due to higher revenues, reduced material costs and operating efficiencies, which was partially offset by higher expenses. Adjusted diluted EPS⁽¹⁾ in the year ended December 31, 2021 was $0.85, an increase of 35% from $0.63 for the year ended December 31, 2020, which reflects growth in adjusted EBITDA⁽¹⁾.

⁽¹⁾ See “Non-GAAP Financial Measures” below.

2022 Financial Guidance

Amneal’s 2022 estimates are based on management's current expectations, including with respect to prescription trends, pricing levels, the timing of future product launches, the costs incurred and benefits realized of restructuring activities, and our long-term strategy. The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The Company cannot provide a reconciliation between non-GAAP projections and the most directly comparable measures in accordance with GAAP without unreasonable efforts because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items required for the reconciliation. The items include, but are not limited to, acquisition-related expenses, restructuring expenses and benefits, asset impairments and other gains and losses. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results.

Conference Call Information

Amneal will host a conference call and live webcast at 8:30 am Eastern Time on March 2, 2022 to discuss its results. The live webcast and presentation will be accessible through the Investor Relations section of the Company’s website at https://investors.amneal.com. To access the call through a conference line, dial (844) 200-6205 (in the U.S.) or (929) 526-1599 (international callers). The access code for the call is 086998. A replay of the conference call will be posted shortly after the call and will be available for seven days. To access the replay, dial (866) 813-9403 (in the U.S.) or +44 (204) 525-0658 (international callers). The access code for the replay is 311554.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products 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. For more information, please visit www.amneal.com.

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 or forecasts for the future, including among other things: discussions of future operations; expected operating results and financial performance; impact of planned acquisitions and dispositions; the Company’s strategy for growth; product development; regulatory approvals; market position and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words 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. 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 ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; 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; the impact of severe weather; the impact of the ongoing COVID-19 pandemic; 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 product liability and other claims against us by consumers and other 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; the impact of global economic conditions; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; 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 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.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted diluted earnings per share, adjusted gross profit, adjusted gross margin, adjusted operating income, adjusted cost of goods sold, adjusted selling general and administrative expense, and adjusted research and development expense, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. The calculation of non-GAAP adjusted diluted earnings per share assumes the conversion of all outstanding shares of class B Common Stock to shares of class A Common Stock under the if-converted method.

Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company's operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company's operations and underlying operational performance. The compensation committee of the Company’s board of directors also uses certain of these measures to evaluate management's performance and set its compensation. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operation and trends while viewing the information through the eyes of management.

These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs; and do not reflect interest expense, or the requirements necessary to service interest or principal payments on debt. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to net income, diluted earnings per share, gross profit, gross margin, operating income, cost of goods sold, selling general and administrative expense, and research and development expense or any other measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business.

A reconciliation of each historical non-GAAP measure to the most directly comparable GAAP measure is set forth below.

Anthony DiMeo
Senior Director, Investor Relations
anthony.dimeo@amneal.com