Form 8-K - Current report

Share Name	Share Symbol	Market	Type
Amneal Pharmaceuticals Inc	NASDAQ:AMRX	NASDAQ	Common Stock

	Price Change	% Change	Share Price	Bid Price	Offer Price	High Price	Low Price	Open Price	Shares Traded	Last Trade
	-0.37	-4.58%	7.70	7.65	8.19	8.05	7.59	8.05	1,398,770	01:00:00

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): August 7, 2024

AMNEAL PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38485

93-4225266

(State or other jurisdiction
of incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

400 Crossing Blvd

Bridgewater, NJ 08807

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (908) 947-3120

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Class A Common Stock, par value $0.01 per share

AMRX

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Item 2.02			Results of Operations and Financial Condition.

On August 9, 2024, Amneal Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its results for the second quarter ended June 30, 2024. A copy of the press release is attached hereto as Exhibit 99.2 and incorporated by reference herein.

In accordance with General Instruction B.2 of Form 8-K, the information under Item 2.02 of this report, including Exhibit 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended (the "Securities Act"), if such subsequent filing specifically references the information furnished pursuant to Item 2.02 of this report.


Item 7.01			Regulation FD.

Conference Call to Discuss Results

Amneal will host a conference call and live webcast at 8:30 am Eastern Time on August 9, 2024, 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 (833) 470-1428 (in the U.S.) with access code 462066. A replay of the conference call will be posted shortly after the call and will be available for seven days. For a list of toll-free international numbers, visit this website: https://www.netroadshow.com/events/global-numbers?confId=52762.

The Company intends to publish an investor presentation that can be accessed at the Investors section of the Company’s website, https://investors.amneal.com, under the “Events & Presentations” heading.

FDA Approval of CREXONT®.

On August 7, 2024, the Company issued a press release announcing that the U.S. Food and Drug Administration has approved CREXONT® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson's disease. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

In accordance with General Instruction B.2 of Form 8-K, the information referenced under Item 7.01 of this report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act if such subsequent filing specifically references the information furnished pursuant to Item 7.01 of this report.


Item 9.01			Financial Statements and Exhibits.

(d) Exhibits.

The following exhibits are furnished herewith:


Exhibit No.						Description

99.1						Press release announcing approval of CREXONT® issued August 7, 2024
99.2						Press release announcing results issued August 9, 2024
104						The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Date: August 9, 2024	AMNEAL PHARMACEUTICALS, INC.

	By:	/s/ Anastasios Konidaris
	Name:	Anastasios Konidaris
	Title:	Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)

Exhibit 99.1

Amneal Receives U.S. FDA Approval for IPX203 for Treatment of Parkinson’s Disease to be launched as CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules

Delivers more “Good On” time with less frequent dosing compared to Immediate Release CD/LD

Underscores Amneal’s leadership in Parkinson’s disease and commitment to one million people currently living with Parkinson’s disease in the U.S.

CREXONT commercial launch planned in September 2024

BRIDGEWATER, N.J., August 7, 2024 -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved CREXONT® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). CREXONT is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets.

“The approval of CREXONT is a seminal moment in the treatment paradigm for Parkinson’s disease. The burden of this incurable neurodegenerative disease increases with time. Some PD patients on IR CD/LD take up to 10 daily doses and still experience motor fluctuations. CREXONT’s innovative formulation provides a longer duration of “Good On” time with less frequent dosing compared to IR CD/LD. Amneal is so excited to introduce this meaningful new treatment for Parkinson’s patients in the U.S. and soon internationally. We are committed to continuing to advance Parkinson’s research and development as a leader in the space,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal.

Existing oral IR CD/LD products are short-acting, and patients can experience more motor fluctuations and less daily “Good On” time, defined as “On” time without troublesome dyskinesia, as the disease progresses. There are approximately one million people with PD living in the U.S. and approximately 90,000 new cases diagnosed each year. One new patient is diagnosed with Parkinson’s disease every six minutes. In the treatment of PD, there is a need for improved oral CD/LD formulations that achieve more “Good On” time with fewer daily doses.

CREXONT’s therapeutic benefits include:

•More “Good On” time with less frequent dosing: CREXONT demonstrated a statistically significant improvement of 0.5 hours of additional “Good On” time per day compared to IR CD/LD, with an average of three times a day dosing with CREXONT compared to five times a day dosing with IR CD/LD, in the RISE-PD clinical trial. A post-hoc analysis of the primary endpoint on a per dose basis showed 1.6 hours additional “Good On” time per dose of CREXONT, compared to IR CD/LD.

•Novel formulation designed to provide long lasting efficacy: CREXONT is an innovative formulation consisting of IR granules with carbidopa and levodopa for rapid onset of action, and ER pellets with levodopa for long-lasting efficacy.

•Safety profile consistent with IR CD/LD: The most common adverse reactions with CREXONT (incidence ≥3% and greater than IR CD/LD) are nausea and anxiety. See Important Safety Information below.

“The treatment goals for people living with Parkinson’s disease include achieving a more robust duration of benefit per dose of LD, reducing ‘Off’ time, and simplifying dosing regimens. CREXONT’s longer ‘Good On’ time per day and per dose represents a substantial advancement in managing motor symptoms and maintaining more consistent therapeutic effects, which is very encouraging for both patients and the

Parkinson’s community,” said Robert A. Hauser, M.D., Professor of Neurology at the University of South Florida and Director of the Parkinson's Disease and Movement Disorders Center.

“People living with Parkinson’s disease experience a notable decrease in quality of life over time and they experience more ‘Off’ time and other side effects. As the PD community explores treatment options that address the challenges faced by people with Parkinson's disease and their families, we champion advances like CREXONT that improve ‘Good On' time, allowing people more time to do the things they love with the people they love,” said Andrea Merriam, Chief Executive Officer of Parkinson & Movement Disorder Alliance.

Amneal expects to make CREXONT available to patients in the U.S. in September 2024.

About CREXONT

CREXONT is an innovative formulation consisting of IR granules with carbidopa and levodopa for rapid onset of action, and ER pellets with levodopa for long-lasting efficacy. CREXONT formulation and dosage strengths are different from RYTARY® (carbidopa and levodopa) extended-release capsules approved by the U.S. FDA in 2015.

INDICATION

CREXONT (carbidopa and levodopa) extended-release capsules is a prescription medication for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.

IMPORTANT SAFETY INFORMATION

•Do not take CREXONT with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors.

•Do not take CREXONT with other carbidopa-levodopa preparations without consulting your healthcare provider.

•CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. Avoid activities that require alertness such as driving and operating machinery, until you know how CREXONT affects you.

•The most common side effects that may occur with CREXONT are nausea and anxiety.

•Avoid sudden discontinuation or rapid dose reduction with CREXONT. If you are discontinuing CREXONT, work with your healthcare provider to taper the dose over time to reduce the risk of fever or confusion.

•You may take CREXONT with or without food; but taking it with food may decrease or delay its effect. Consider taking the first dose of the day about 1 to 2 hours before eating.

•Swallow CREXONT whole. Do not chew, divide, or crush the capsules.

•Do not take CREXONT with alcohol.

Tell your healthcare provider if you:

•Have any heart conditions, especially if you have had a heart attack or irregular heartbeats.

•Experience hallucinations or abnormal thoughts and behaviors.

•Have an inability to control urges to gamble, have increased sexual urges, or experience other intense urges.

•Have thoughts of suicide or have attempted suicide.

•Have abnormal involuntary movements that appear or get worse during treatment.

•Have ever had a peptic ulcer or glaucoma.

•Become or intend to become pregnant. Based on animal data, CREXONT may cause fetal harm.

•Are breastfeeding during therapy.

•Have side effects; your doctor can adjust your dose.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals, LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the full Prescribing Information here: www.amneal.com/pi/crexont.pdf. For more information talk to your healthcare provider.

About Parkinson’s Disease

Parkinson’s disease (PD) has become the fastest growing neurological disorder worldwide, with approximately 1 million people diagnosed in the U.S.1,2 It is a progressive disorder of the central nervous system (CNS) that affects dopamine-producing neurons in the brain that affect movement. PD is characterized by slowness of movement, stiffness, resting tremor and impaired balance.3 While PD is not considered a fatal disease, it is associated with significant morbidity and disability.4 The average age at diagnosis for people with PD is 60; as people live longer, the number of people living with PD is predicted to grow significantly over the coming decades.1,5

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. 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, 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.

References:

1.Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.

2.Marras et al. NPJ Parkinson’s Dis. 2018;4:21.

3.NINDS. Parkinson’s disease: challenges, progress, and promise. Reviewed August 2019.

4.Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.

5.Johns Hopkins Medicine. Young-Onset Parkinson’s Disease.

Investor Contact
Anthony DiMeo
VP, Investor Relations & Media
anthony.dimeo@amneal.com

Media Contact
Rachel Girard

Senior Director, Media and Engagement, Real Chemistry

rgirard@realchemistry.com

Amneal Medical Affairs
888-990-AMRX (2679)
askamrx@amneal.com

Exhibit 99.2

AMNEAL REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS

‒ Q2 2024 Net Revenue of $702 million; GAAP Net Income of $6 million; Diluted Income per Share of $0.02 ‒

‒ Adjusted EBITDA of $162 million; Adjusted Diluted EPS of $0.16 ‒

‒ Raising 2024 Full Year Guidance ‒

‒ CREXONT® U.S. FDA approval represents an exciting new long-term growth driver ‒

BRIDGEWATER, NJ, August 9, 2024 - Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced its results today for the second quarter ended June 30, 2024.

“Amneal achieved strong revenues and adjusted EBITDA in the second quarter, and we are pleased to raise full year 2024 guidance driven by broad-based growth across our business. Amneal is a diversified and growing global pharmaceuticals company built on our core strengths in quality, innovation and operational execution. Coupled with this week’s approval of CREXONT for Parkinson’s disease, Amneal is well positioned to continue delivering durable long-term growth. We are excited about the big opportunities ahead as we focus on the most important areas of medicine to create value for patients, providers and all stakeholders,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

Second Quarter 2024 Results

Net revenue in the second quarter of 2024 was $702 million, an increase of 17% compared to $599 million in the second quarter of 2023. Generics net revenue increased 14% driven primarily by biosimilars and new product launches. Specialty net revenue increased 7% driven by promoted products in Neurology and Endocrinology. AvKARE net revenue increased 33% driven by continued growth across its sales channels.

Net income attributable to Amneal Pharmaceuticals, Inc. was $6 million in the second quarter of 2024 compared to $12 million in the second quarter of 2023.

Adjusted EBITDA in the second quarter of 2024 was $162 million, an increase of 11% compared to the second quarter of 2023, reflective of strong revenue performance partially offset by the impact of business mix on gross margins and higher commercial spend to support new products.

Diluted income per share in the second quarter of 2024 was $0.02 compared to $0.08 for the second quarter of 2023, primarily due to lower net income. Adjusted diluted earnings per share in the second quarter of 2024 was $0.16 compared to $0.19 for the second quarter of 2023 due to the aforementioned factor.

The Company presents GAAP and adjusted (non-GAAP) quarterly results. Please refer to the “Non-GAAP Financial Measures” section for more information. In the tables provided below, GAAP to non-GAAP reconciliations are presented.

Raising Full Year 2024 Guidance

The Company is raising its previously provided full year 2024 guidance.


	Updated Guidance	Prior Guidance
Net revenue	$2.70 billion - $2.80 billion	$2.55 billion - $2.65 billion
Adjusted EBITDA (1)	$610 million - $630 million	$580 million - $620 million
Adjusted diluted EPS (2)	$0.57 - $0.63	$0.53 - $0.63
Operating cash flow (3)	$280 million - $320 million	$260 million - $300 million
Capital expenditures	$60 million - $70 million	$60 million - $70 million

(1) Includes 100% of Adjusted EBITDA from the AvKARE acquisition.

(2)Accounts for 35% non-controlling interest in AvKARE. Updated guidance and prior guidance assume weighted-average diluted shares outstanding of approximately 320 million and 317 million for the year ending December 31, 2024, respectively.

(3) Does not contemplate one-time and non-recurring items such as legal settlements and other discrete items.

Amneal’s 2024 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, legal settlements, 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 today, August 9, 2024, 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 (833) 470-1428 (in the U.S.) with access code 462066. A replay of the conference call will be posted shortly after the call and will be available for seven days. For a list of toll-free international numbers, visit this website: https://www.netroadshow.com/events/global-numbers?confId=52762.

About Amneal

Cautionary Statement on Forward-Looking Statements

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.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income and adjusted diluted EPS, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Adjusted diluted EPS reflects diluted earnings (loss) per share based on adjusted net income (loss), which is net loss adjusted to (A) exclude (i) non-cash interest, (ii) GAAP provision for (benefit from) income taxes, (iii) amortization, (iv) stock-based compensation, (v) acquisition, site closure expenses, and idle facility expenses, (vi) restructuring and other charges, (vii) charges related to certain legal matters, including interest, net, (viii) asset impairment charges, (ix) change in fair value of contingent consideration, (x) increase in tax receivable agreement liability, (xi) system implementation expense, (xii) other and (xiii) net income attributable to non-controlling interests not associated with our Class B common stock, and (B) include non-GAAP provision for income taxes. Non-GAAP adjusted diluted EPS for the three and six months ended June 30, 2024 was calculated using the weighted average fully diluted shares outstanding of Class A common stock. Non-GAAP adjusted diluted EPS for the three and six months ended June 30, 2023 was calculated using the weighted average diluted shares outstanding of Class A common stock and assuming all shares of Class B common stock were converted to shares of Class A common stock as of January 1, 2023.

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 operations 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 any 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.

Contact

Anthony DiMeo

VP, Investor Relations & Media

anthony.dimeo@amneal.com

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Operations

(unaudited; $ in thousands, except per share amounts)


	Three Months Ended June 30,				Six Months Ended June 30,
	2024		2023		2024		2023
Net revenue	$	701,780	$	599,046	$	1,360,971	$	1,156,586
Cost of goods sold	451,833		379,025		872,964		758,379
Gross profit	249,947		220,021		488,007		398,207
Selling, general and administrative	116,462		105,570		229,057		207,666
Research and development	36,054		37,799		75,352		76,489
Intellectual property legal development expenses	1,042		820		2,026		2,464
Restructuring and other charges	220		82		1,690		592
Change in fair value of contingent consideration	—		(6,364)		100		(3,907)
Charges related to legal matters, net	699		2,017		95,058		1,581
Other operating expense (income)	—		13		—		(1,211)
Operating income	95,470		80,084		84,724		114,533
Other (expense) income:
Interest expense, net	(65,719)		(50,857)		(131,422)		(100,172)
Foreign exchange (loss) gain, net	(262)		421		(1,459)		2,322
Increase in tax receivable agreement liability	(13,444)		(405)		(15,392)		(1,231)
Other income, net	4,360		417		8,432		4,782
Total other expense, net	(75,065)		(50,424)		(139,841)		(94,299)
Income (loss) before income taxes	20,405		29,660		(55,117)		20,234
Provision for (benefit from) income taxes	3,618		(23)		9,774		645
Net income (loss)	16,787		29,683		(64,891)		19,589
Less: Net income attributable to non-controlling interests	(10,793)		(17,766)		(20,758)		(14,615)
Net income (loss) attributable to Amneal Pharmaceuticals, Inc.	$	5,994	$	11,917	$	(85,649)	$	4,974

Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.'s Class A common stockholders:
Basic	$	0.02	$	0.08	$	(0.28)	$	0.03
Diluted	$	0.02	$	0.08	$	(0.28)	$	0.03
Weighted-average common shares outstanding(1):
Basic	309,117		153,738		308,198		152,928
Diluted	318,957		154,887		308,198		154,575

(1)Following the implementation of the Reorganization on November 7, 2023, all outstanding shares of Old PubCo Class A Common Stock and Old PubCo Class B Common Stock were exchanged for an equivalent number of shares of Class A common stock of the Company. Refer to Note 1. Nature of Operations and Note 8. (Loss) Earnings per Share to the consolidated financial statements in the Company’s 2023 Annual Report on Form 10-K for additional information.

Amneal Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited; $ in thousands)


	June 30, 2024		December 31, 2023
Assets
Current assets:
Cash and cash equivalents	$	43,769	$	91,542
Restricted cash	5,853		7,565
Trade accounts receivable, net	769,871		613,732
Inventories	575,624		581,384
Prepaid expenses and other current assets	81,596		82,685
Related party receivables	8,767		955
Total current assets	1,485,480		1,377,863
Property, plant and equipment, net	425,380		447,574
Goodwill	598,533		598,629
Intangible assets, net	819,944		890,423
Operating lease right-of-use assets	33,284		30,329
Operating lease right-of-use assets - related party	11,974		12,954
Financing lease right-of-use assets	58,299		59,280
Other assets	77,028		55,517
Total assets	$	3,509,922	$	3,472,569
Liabilities and Stockholders' (Deficiency) Equity
Current liabilities:
Accounts payable and accrued expenses	$	619,194	$	534,662
Current portion of liabilities for legal matters	30,740		76,988
Revolving credit facility	179,000		179,000
Current portion of long-term debt, net	225,156		34,125
Current portion of operating lease liabilities	9,669		9,207
Current portion of operating lease liabilities - related party	3,259		2,825
Current portion of financing lease liabilities	3,199		2,467
Related party payables - short term	12,773		7,321
Current portion of notes payable - related party	31,363		—
Total current liabilities	1,114,353		846,595
Long-term debt, net	2,177,578		2,386,004
Note payable - related party	—		41,447
Operating lease liabilities	26,782		24,095
Operating lease liabilities - related party	11,126		12,787
Financing lease liabilities	58,007		58,566
Related party payables - long term	16,146		11,776
Liabilities for legal matters - long term	85,479		316
Other long-term liabilities	24,518		29,679
Total long-term liabilities	2,399,636		2,564,670
Redeemable non-controlling interests	53,422		41,293
Total stockholders' (deficiency) equity	(57,489)		20,011
Total liabilities and stockholders' (deficiency) equity	$	3,509,922	$	3,472,569

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(unaudited; $ in thousands)


	Six Months Ended June 30,
	2024		2023
Cash flows from operating activities:
Net (loss) income	$	(64,891)	$	19,589
Adjustments to reconcile net (loss) income to net cash provided by operating activities:
Depreciation and amortization	111,100		115,261
Unrealized foreign currency loss (gain)	2,080		(1,561)
Amortization of debt issuance costs and discount	1,221		4,523
Intangible asset impairment charges	920		1,283
Change in fair value of contingent consideration	100		(3,907)
Stock-based compensation	13,446		14,157
Inventory provision	41,493		41,806
Other operating charges and credits, net	(1,531)		3,364
Changes in assets and liabilities:
Trade accounts receivable, net	(155,843)		66,976
Inventories	(35,447)		(60,526)
Prepaid expenses, other current assets and other assets	(8,418)		31,898
Related party receivables	(628)		351
Accounts payable, accrued expenses and other liabilities	122,026		(107,760)
Related party payables	9,619		2,913
Net cash provided by operating activities	35,247		128,367
Cash flows from investing activities:
Purchases of property, plant and equipment	(19,824)		(21,691)
Acquisition of intangible assets	(10,450)		(1,488)
Deposits for future acquisition of property, plant and equipment	(940)		(842)
Proceeds from sale of subsidiary	4,989		—
Net cash used in investing activities	(26,225)		(24,021)
Cash flows from financing activities:
Payments of principal on debt, revolving credit facilities, financing leases and other	(78,877)		(87,566)
Borrowings on revolving credit facilities	48,000		100,000
Proceeds from exercise of stock options	386		—
Employee payroll tax withholding on restricted stock unit vesting	(7,371)		(2,033)
Tax distributions to non-controlling interests	(8,883)		(35,557)
Payment of principal on notes payable - related party	(11,496)		—
Net cash used in financing activities	(58,241)		(25,156)
Effect of foreign exchange rate on cash	(266)		165
Net (decrease) increase in cash, cash equivalents, and restricted cash	(49,485)		79,355
Cash, cash equivalents, and restricted cash - beginning of period	99,107		35,227
Cash, cash equivalents, and restricted cash - end of period	$	49,622	$	114,582
Cash and cash equivalents - end of period	$	43,769	$	109,284
Restricted cash - end of period	5,853		5,298
Cash, cash equivalents, and restricted cash - end of period	$	49,622	$	114,582

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(unaudited, $ in thousands)

Reconciliation of Net Income (Loss) to EBITDA and Adjusted EBITDA


	Three Months Ended June 30,				Six Months Ended June 30,
	2024		2023		2024		2023
Net income (loss)	$	16,787	$	29,683	$	(64,891)	$	19,589
Adjusted to add:
Interest expense, net	65,719		50,857		131,422		100,172
Provision for (benefit from) income taxes	3,618		(23)		9,774		645
Depreciation and amortization	55,572		57,111		111,100		115,261
EBITDA (Non-GAAP)	$	141,696	$	137,628	$	187,405	$	235,667
Adjusted to add (deduct):
Stock-based compensation expense	6,725		6,561		13,231		14,157
Acquisition, site closure, and idle facility expenses (1)	579		1,579		1,023		4,280
Restructuring and other charges	131		82		1,601		493
Charges related to legal matters, net (2)	699		2,017		95,058		6,081
Asset impairment charges	—		1,338		1,015		2,071
Foreign exchange loss (gain)	262		(421)		1,459		(2,322)
Change in fair value of contingent consideration	—		(6,364)		100		(3,907)
Increase in tax receivable agreement liability	13,444		405		15,392		1,231
System implementation expense (3)	855		1,641		1,772		2,413
Other	(2,180)		1,622		(3,494)		2,104
Adjusted EBITDA (Non-GAAP)	$	162,211	$	146,088	$	314,562	$	262,268

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(unaudited; in thousands, except per share amounts)

Reconciliation of Net Income (Loss) to Adjusted Net Income and Calculation of Adjusted Diluted Earnings Per Share


	Three Months Ended June 30,				Six Months Ended June 30,
	2024		2023		2024		2023
Net income (loss)	$	16,787	$	29,683	$	(64,891)	$	19,589
Adjusted to add (deduct):
Non-cash interest	547		2,112		629		3,953
GAAP provision for (benefit from) income taxes	3,618		(23)		9,774		645
Amortization	38,818		39,309		77,489		78,920
Stock-based compensation expense	6,725		6,561		13,231		14,157
Acquisition, site closure expenses, and idle facility expenses (1)	579		1,579		1,023		4,280
Restructuring and other charges	131		82		1,584		493
Charges related to legal matters, including interest, net (2)	699		2,725		95,185		7,607
Asset impairment charges	—		1,331		1,015		2,064
Change in fair value of contingent consideration	—		(6,364)		100		(3,907)
Increase in tax receivable agreement liability	13,444		405		15,392		1,231
System implementation expense (3)	855		1,641		1,772		2,413
Other	(2,180)		1,620		(3,494)		2,251
Provision for income taxes (4)	(17,800)		(16,495)		(32,141)		(27,324)
Net income attributable to non-controlling interests not associated with our Class B common stock	(10,793)		(7,292)		(20,758)		(12,687)
Adjusted net income (Non-GAAP)	$	51,430	$	56,874	$	95,910	$	93,685
Weighted average diluted shares outstanding (Non-GAAP) (5)	318,957		307,004		317,758		306,691
Adjusted diluted earnings per share (Non-GAAP)	$	0.16	$	0.19	$	0.30	$	0.31

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(unaudited)

Explanations for Reconciliations of Net Income (Loss) to EBITDA and Adjusted EBITDA and Net Income (Loss) to Adjusted Net Income and Calculation of Adjusted Diluted Earnings per Share

(1)Acquisition, site closure, and idle facility expenses for the three and six months ended June 30, 2024 primarily included rent for vacated properties. Acquisition, site closure, and idle facility expenses for the three and six months ended June 30, 2023 primarily included site closure costs associated with the planned cessation of manufacturing at our Hauppauge, NY facility.

(2)For the six months ended June 30, 2024, charges related to legal matters, net were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the Company by political subdivisions and Native American tribes across the United States.

(3)System implementation expense for the three and six months ended June 30, 2024 and 2023 was primarily for the implementation of software to further integrate our acquired businesses.

(4)The non-GAAP effective tax rates for the three and six months ended June 30, 2024 were 25.7% and 25.1%, respectively. The non-GAAP effective tax rates for the three and six months ended June 30, 2023 were 22.5% and 22.6%, respectively.

(5)Weighted average diluted shares outstanding for the three and six months ended June 30, 2024 consisted of fully diluted Class A common stock. Weighted average diluted shares outstanding for the three and six months ended June 30, 2023 consisted of diluted Class A common stock and Class B common stock, as if all shares of Class B common stock were converted to Class A common stock as of January 1, 2023.

Amneal Pharmaceuticals, Inc.

Generics Segment

Reconciliation of GAAP to Non-GAAP Operating Results (1)

(unaudited; $ in thousands)


	Three Months Ended June 30, 2024								Three Months Ended June 30, 2023
	As Reported			Adjustments		Non-GAAP			As Reported			Adjustments		Non-GAAP
Net revenue	$	427,328		$	—	$	427,328		$	373,701		$	—	$	373,701
Cost of goods sold (2)	260,903			(11,444)		249,459			225,189			(13,404)		211,785
Gross profit	166,425			11,444		177,869			148,512			13,404		161,916
Gross margin %	38.9		%			41.6		%	39.7		%			43.3		%

Selling, general and administrative (3)	31,627			(1,591)		30,036			28,040			(2,597)		25,443
Research and development (4)	31,703			(584)		31,119			31,108			(325)		30,783
Intellectual property legal development expenses	1,032			—		1,032			801			—		801
Restructuring and other charges	53			(53)		—			—			—		—
Charges related to legal matters, net	699			(699)		—			2,017			(2,017)		—
Other operating income	—			—		—			13			—		13
Operating income	$	101,311		$	14,371	$	115,682		$	86,533		$	18,343	$	104,876

(1)Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)Adjustments for the three months ended June 30, 2024 and 2023, respectively, were comprised of stock-based compensation expense ($0.9 million and $0.3 million), amortization expense ($10.5 million and $10.8 million), site closure and idle facility expenses (none and $1.0 million), and asset impairment charges (none and $1.3 million).

(3)Adjustments for the three months ended June 30, 2024 and 2023, respectively, were comprised of stock-based compensation expense ($1.0 million and $2.0 million) and site closure costs ($0.6 million in each period).

(4)Adjustments for the three months ended June 30, 2024 and 2023 were comprised of stock-based compensation expense.

Amneal Pharmaceuticals, Inc.

Generics Segment

Reconciliation of GAAP to Non-GAAP Operating Results (1)

(unaudited; $ in thousands)


	Six Months Ended June 30, 2024								Six Months Ended June 30, 2023
	As Reported			Adjustments		Non-GAAP			As Reported			Adjustments		Non-GAAP
Net revenue	$	818,622		$	—	$	818,622		$	717,507		$	—	$	717,507
Cost of goods sold (2)	500,825			(23,712)		477,113			455,740			(28,846)		426,894
Gross profit	317,797			23,712		341,509			261,767			28,846		290,613
Gross margin %	38.8		%			41.7		%	36.5		%			40.5		%

Selling, general and administrative (3)	64,712			(3,320)		61,392			55,640			(3,876)		51,764
Research and development (4)	66,074			(1,239)		64,835			63,467			(1,268)		62,199
Intellectual property legal development expenses	1,992			—		1,992			2,425			—		2,425
Restructuring and other charges	53			(53)		—			99			—		99
Charges (credit) related to legal matters, net (5)	95,058			(95,058)		—			(427)			(4,073)		(4,500)
Other operating income	—			—		—			(1,211)			—		(1,211)
Operating income	$	89,908		$	123,382	$	213,290		$	141,774		$	38,063	$	179,837

(1)Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)Adjustments for the six months ended June 30, 2024 and 2023, respectively, were comprised of stock-based compensation expense ($1.8 million and $2.0 million), amortization expense ($20.9 million and $21.6 million), site closure and idle facility expenses (none and $3.1 million), asset impairment charges ($1.0 million and $2.0 million), and other (none and $0.1 million).

(3)Adjustments for the six months ended June 30, 2024 and 2023, respectively, were comprised of stock-based compensation expense ($2.3 million and $2.7 million) and site closure costs ($1.0 million and $1.2 million).

(4)Adjustments for the six months ended June 30, 2024 and 2023 were comprised of stock-based compensation expense.

(5)Adjustments for the six months ended June 30, 2024 were associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the Company by political subdivisions and Native American tribes across the United States.

Amneal Pharmaceuticals, Inc.

Specialty Segment

Reconciliation of GAAP to Non-GAAP Operating Results

(unaudited; $ in thousands)


	Three Months Ended June 30, 2024								Three Months Ended June 30, 2023
	As Reported			Adjustments		Non-GAAP			As Reported			Adjustments		Non-GAAP
Net revenue	$	104,041		$	—	$	104,041		$	96,994		$	—	$	96,994
Cost of goods sold (1)	46,142			(25,977)		20,165			46,512			(25,844)		20,668
Gross profit	57,899			25,977		83,876			50,482			25,844		76,326
Gross margin %	55.7		%			80.6		%	52.0		%			78.7		%

Selling, general and administrative (2)	26,610			(317)		26,293			22,759			(228)		22,531
Research and development (2)	4,351			(259)		4,092			6,691			(487)		6,204
Intellectual property legal development expenses	10			—		10			19			—		19
Restructuring and other charges	78			(78)		—			82			(82)		—
Change in fair value of contingent consideration (3)	—			—		—			(6,364)			6,364		—
Operating income	$	26,850		$	26,631	$	53,481		$	27,295		$	20,277	$	47,572

(1)Adjustments for the three months ended June 30, 2024 and 2023 were comprised of amortization expense.

(2)Adjustments for the three months ended June 30, 2024 and 2023 were comprised of stock-based compensation expense.

(3)Contingent consideration was recorded in connection with the acquisitions of (i) the baclofen franchise from certain entities affiliated with Saol International Limited and (ii) Kashiv Specialty Pharmaceuticals, LLC.

Amneal Pharmaceuticals, Inc.

Specialty Segment

Reconciliation of GAAP to Non-GAAP Operating Results

(unaudited; $ in thousands)


	Six Months Ended June 30, 2024								Six Months Ended June 30, 2023
	As Reported			Adjustments		Non-GAAP			As Reported			Adjustments		Non-GAAP
Net revenue	$	209,275		$	—	$	209,275		$	188,672		$	—	$	188,672
Cost of goods sold (1)	90,942			(51,955)		38,987			89,703			(52,027)		37,676
Gross profit	118,333			51,955		170,288			98,969			52,027		150,996
Gross margin %	56.5		%			81.4		%	52.5		%			80.0		%

Selling, general and administrative (2)	51,806			(588)		51,218			45,138			(414)		44,724
Research and development (2)	9,278			(543)		8,735			13,022			(876)		12,146
Intellectual property legal development expenses	34			—		34			39			—		39
Restructuring and other charges	1,024			(1,024)		—			82			(82)		—
Change in fair value of contingent consideration (3)	100			(100)		—			(3,907)			3,907		—
Operating income	$	56,091		$	54,210	$	110,301		$	44,595		$	49,492	$	94,087

(1)Adjustments for the six months ended June 30, 2024 and 2023 were comprised of amortization expense.

(2)Adjustments for the six months ended June 30, 2024 and 2023 were comprised of stock-based compensation expense.

Amneal Pharmaceuticals, Inc.

AvKARE Segment

Reconciliation of GAAP to Non-GAAP Operating Results (1)

(unaudited; $ in thousands)


	Three Months Ended June 30, 2024								Three Months Ended June 30, 2023
	As Reported			Adjustments		Non-GAAP			As Reported			Adjustments		Non-GAAP
Net revenue	$	170,411		$	—	$	170,411		$	128,351		$	—	$	128,351
Cost of goods sold	144,788			—		144,788			107,324			—		107,324
Gross profit	25,623			—		25,623			21,027			—		21,027
Gross margin %	15.0		%			15.0		%	16.4		%			16.4		%

Selling, general and administrative (2)	14,642			(3,546)		11,096			14,015			(4,188)		9,827
Operating income	$	10,981		$	3,546	$	14,527		$	7,012		$	4,188	$	11,200

(1)Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)Adjustments for the three months ended June 30, 2024 and 2023 were comprised of amortization expense.

Amneal Pharmaceuticals, Inc.

AvKARE Segment

Reconciliation of GAAP to Non-GAAP Operating Results (1)

(unaudited; $ in thousands)


	Six Months Ended June 30, 2024								Six Months Ended June 30, 2023
	As Reported			Adjustments		Non-GAAP			As Reported			Adjustments		Non-GAAP
Net revenue	$	333,074		$	—	$	333,074		$	250,407		$	—	$	250,407
Cost of goods sold	281,197			—		281,197			212,936			—		212,936
Gross profit	51,877			—		51,877			37,471			—		37,471
Gross margin %	15.6		%			15.6		%	15.0		%			15.0		%

Selling, general and administrative (2)	29,549			(7,091)		22,458			26,955			(7,952)		19,003
Operating income	$	22,328		$	7,091	$	29,419		$	10,516		$	7,952	$	18,468

(1)Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)Adjustments for the six months ended June 30, 2024 and 2023, respectively, were comprised of amortization expense ($7.1 million and $8.4 million) and other (none and ($0.4) million).

Document and Entity Information Document	Aug. 04, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 07, 2024
Entity Registrant Name	AMNEAL PHARMACEUTICALS, INC.
Entity Central Index Key	0001723128
Entity Emerging Growth Company	false
Entity File Number	001-38485
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	93-4225266
Entity Address, Address Line One	400 Crossing Blvd
Entity Address, City or Town	Bridgewater
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08807
City Area Code	908
Local Phone Number	947-3120
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Class A Common Stock, par value $0.01 per share
Trading Symbol	AMRX
Security Exchange Name	NASDAQ

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AMRX Amneal Pharmaceuticals Inc