AMRX - Amneal Reports Second Quarter 2020 Financial Results

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (the “Company”) announced its results today for the second quarter ended June 30, 2020.

“Amneal executed well against our operational and strategic goals in the second quarter and, even in the face of COVID-related headwinds, delivered strong financial results,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “Our commitment to execution, innovation and cost efficiency continues to drive growth across our Generics, Specialty and AvKARE segments and positions us well for the remainder of 2020 and beyond. We are extremely proud of our employees across the globe, who have demonstrated resiliency during this public health crisis and remain dedicated to our mission of bringing affordable medicines to patients.”

Net revenue in the second quarter of 2020 was $465 million, an increase of 15% compared to $405 million in the second quarter of 2019, primarily due to the acquisition of 65% of AvKARE and its related entities, hereinafter referred to as “AvKARE” and growth of our Specialty segment. Net loss attributable to Amneal Pharmaceuticals, Inc. of $12 million in the second quarter compared to a net loss of $17 million in prior year period, reflects higher gross profit and lower interest expense, partially offset by higher operating expenses related to AvKARE. Diluted loss per share in the second quarter was $0.08 compared to a loss of $0.13 in the prior year period.

Adjusted EBITDA⁽¹⁾ in the second quarter of 2020 was $101 million, an increase of 9% compared to the prior year period, primarily due to higher gross profit partially offset by higher operating expenses. Adjusted net income⁽¹⁾ in the second quarter was $38 million, an increase of 42% compared to the prior year period, and primarily reflects higher adjusted EBITDA⁽¹⁾ and lower interest expense, partially offset by higher non-controlling interests due to the acquisition of 65% of AvKARE. Adjusted diluted EPS⁽¹⁾ in the second quarter was $0.13, compared to $0.09 for the prior year period.

Maintaining Full Year 2020 Financial Outlook

Amneal is maintaining its previously provided 2020 guidance; operating cash flow excludes an expected $110 million cash tax refund, of which approximately $106 million was received during July 2020.

Conference Call Information

Amneal will host a conference call and live webcast at 8:30 am Eastern Time on August 6, 2020 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) 746-0741 (in the U.S.) or (412) 317-5273 (international callers). 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 (877) 344-7529 (in the U.S.) or (412) 317-0088 (international callers). The access code for the replay is 10145923.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, 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 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, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” 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: the potential impact of the COVID-19 pandemic on our business, manufacturing, supply chain, financial results, financial condition, and planned capital expenditures and national and international economies, the risk that our goodwill may become impaired, which could adversely affect our financial condition and results of operations, the impact of global economic conditions; our ability to successfully develop, license, acquire and commercialize new products on a timely basis; our ability to obtain exclusive marketing rights for our products; 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 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 risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including United States federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our dependence on third-party agreements for a portion of our product offerings; our ability to identify and make acquisitions of or investments in complementary businesses and products on advantageous terms; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the significant amount of resources we expend on research and development; 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; 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 adjusted EBITDA, adjusted net income, adjusted net income per diluted share, adjusted gross profit, adjusted gross margin and adjusted operating income, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with U.S. General Accepted Accounting Principles (“GAAP”). All business results presented in this release are not prepared in accordance with Article 11 of Regulation S-X. 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.

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 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.

The Company cannot provide a reconciliation between non-GAAP projections and the most directly comparable GAAP measures 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.

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

Generics net revenue was $307 million in the second quarter of 2020 compared to $335 million for the prior year period. The reclassification of Oxymorphone to the Specialty segment and divestiture of our international business in 2019 accounted for $15 million of the quarter to quarter decline. In addition, new product launches in 2019 including EluRyng (Generic NuvaRing) and Sucralfate partially offset base portfolio erosion primarily related to Levothyroxine and Diclofenac Gel generic competition.

Generics gross margin for the second quarter of 2020 was 28% compared to 20% for the prior year period. The increase primarily relates to new product launches and lower inventory related charges, partially offset by erosion and the reclassification of Oxymorphone. Generics adjusted gross margin for the second quarter of 2020 was 35% for the both the current and prior year period.

Generics operating income for the second quarter of 2020 was $27 million compared to of $5 million for the prior year period. The increase primarily reflects the increase in gross margin described above and lower SG&A as well as R&D expenses due to cost reduction initiatives and the timing of expenses in 2020 due to delayed spending as a result of COVID-19.

Generics adjusted operating income for the second quarter of 2020 was $62 million compared to $65 million for the prior year period primarily due to a reduction in Levothyroxine and Diclofenac revenue and the reclassification of Oxymorphone, partially offset by new product launches and a reduction of expenses as a result of cost saving initiatives and delayed spending as a result of COVID-19.

Specialty net revenue was $94 million in the second quarter of 2020 compared to $70 million for the prior year period, primarily due to the reclassification of Oxymorphone to the Specialty segment during the third quarter of 2019, and higher revenue from Rytary® and Unithroid®.

Specialty gross margin for the second quarter of 2020 was 47% compared to 53% for the prior year period primarily due to product sales mix and the impact of Oxymorphone which is a lower margin product.

Specialty adjusted gross margin for the second quarter of 2020 was 74% compared to 82% for the prior year period primarily due to the addition of lower margin Oxymorphone.

Specialty operating income for the second quarter of 2020 was $24 million compared to $17 million for the prior year period, primarily due to higher revenue, partially offset by higher cost of goods sold and R&D expenditures, including IPX203.

Specialty adjusted operating income for the second quarter of 2020 was $50 million compared to $39 million for the prior year period primarily due to the higher revenue.