Endo International : 2022 Irish Statutory Accounts

ENDO INTERNATIONAL PUBLIC LIMITED COMPANY

Directors' Report and Financial Statements For the Year Ended December 31, 2022

ENDO INTERNATIONAL PLC

TABLE OF CONTENTS

	Page
Directors and Other Information	2
Directors' Report	3
Statement of Directors' Responsibilities	78
Independent Auditors' Report to the Members of Endo International plc	79
Consolidated Profit and Loss Account	89
Consolidated Statement of Comprehensive Income	90
Consolidated Balance Sheet	91
Consolidated Statement of Cash Flows	93
Consolidated Reconciliation of Shareholders' Funds	95
Notes to Consolidated Financial Statements	96
Company Reconciliation of Shareholders' Funds	164
Company Balance Sheet	165
Notes to Company Financial Statements	166

1

	DIRECTORS AND OTHER INFORMATION
DIRECTORS	Mark G. Barberio (United States)
	Blaise Coleman (United States)
	Shane M. Cooke (Ireland)
	Nancy J. Hutson, Ph.D. (United States)
	Michael Hyatt (United States)
	William P. Montague (United States)
	M. Christine Smith, Ph.D. (United States)
	Jennifer M. Chao (United States)
REGISTERED OFFICE	First Floor,
	Minerva House,
	Simmonscourt Road,
	Ballsbridge,
	Dublin 4.
	D04 H9P8
REGISTERED NUMBER	534814
SECRETARY	Matthew Maletta (United States)
SOLICITOR	A&L Goodbody,
	IFSC,
	North Wall Quay,
	Dublin 1.
BANKERS	Bank of America,
	2 King Edward Street,
	London EC1A 1HQ.
AUDITORS	PricewaterhouseCoopers,
	Chartered Accountants and
	Statutory Audit Firm,
	One Spencer Dock,
	North Wall Quay,
	Dublin 1.

2

DIRECTORS' REPORT

For the Year Ended December 31, 2022

The directors present their report and audited Consolidated Financial Statements for the year ended December 31, 2022.

Principal Activities

Unless otherwise indicated or required by the context, references throughout to "Endo," the "Group," "we," "our" or "us" refer to Endo International plc and its subsidiaries.

Endo International plc is an Ireland-domiciled specialty pharmaceutical company. Endo International plc was incorporated in Ireland in 2013 as a private limited company and re-registered effective February 18, 2014 as a public limited company. Endo International plc is a holding company that conducts business through its operating subsidiaries.

Our ordinary shares, which previously traded on the Nasdaq Global Select Market under the ticker symbol "ENDP," are currently quoted on the over-the-counter market using the ticker symbol "ENDPQ." References throughout to "ordinary shares" refer to Endo International plc's ordinary shares (1,000,000,000 authorized, par value of $0.0001 per share). In addition, we have 4,000,000 euro deferred shares outstanding (par value of $0.01 per share).

The address of Endo International plc's headquarters is Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland (telephone number: 011-353-1-268-2000).

Our focus is on pharmaceutical products and we target areas where we believe we can build leading positions. Our operating model is based on a lean and nimble structure, the rational allocation of capital and an emphasis on high-value research and development (R&D) targets. While our primary focus is on organic growth, we evaluate and, where appropriate, execute on opportunities to expand through the licensing or acquisition of products or companies in areas that we believe serve patients and customers while offering attractive growth characteristics and margins. We believe our operating model and the execution of our corporate strategy will enable us to create shareholder value over the long-term.

The four reportable business segments in which we operate are: (1) Branded Pharmaceuticals, (2) Sterile Injectables, (3) Generic Pharmaceuticals and (4) International Pharmaceuticals. Additional information about our reportable business segments is included throughout this report. The results of operations of our reportable business segments are discussed in this report under the heading "RESULTS OF OPERATIONS." Across all of our reportable business segments, we generated total turnover of $2.32 billion and $2.99 billion in 2022 and 2021, respectively.

For branded products, which we sell primarily through our Branded Pharmaceuticals and Sterile Injectables segments, we seek to invest in products or product candidates that have inherent scientific, regulatory, legal and technical complexities and market such products under recognizable brand names that are trademarked. For products we develop for the U.S. market, after the completion of required clinical trials and testing, we seek approvals from regulatory bodies such as through the submission of New Drug Applications (NDAs) or Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA). We believe that our patents, the protection of discoveries in connection with our development activities, our proprietary products, technologies, processes, trade secrets, know-how, innovations and all of our intellectual property are important to our business and achieving a competitive position. However, there can be no assurance that any of our patents, licenses or other intellectual property rights will afford us any protection from competition.

Generic products are the pharmaceutical and therapeutic equivalents of branded products and are generally sold under their generic (chemical) names rather than their brand names. For generic products, which we sell primarily through our Sterile Injectables and Generic Pharmaceuticals segments, our focus is on high-barrier-to-entry products, with an emphasis on complex sterile injectable products, such as ready-to-use (RTU) products, and first-to-file or first-to-market opportunities that are difficult to formulate or manufacture or face complex legal and regulatory challenges. In the U.S., first-to-file products refer to generic products for which the Abbreviated New Drug Applications (ANDAs) containing patent challenges (or Paragraph IV certifications) to the corresponding branded products' listed patents were the first to be filed with the FDA. In the U.S., manufacturers that launch first-to-file products, after success in litigating or otherwise resolving related patent challenges, and receive final FDA approval have the opportunity for 180 days of generic marketing exclusivity from competing generic products other than authorized generics. First-to-market products refer to products that are the first marketed generic equivalents of the corresponding branded products for reasons apart from statutory marketing exclusivity. This can occur, for example, when a generic product is difficult to formulate or manufacture. First-to-market products allow manufacturers to mitigate risks from competitive pressures commonly associated with commoditized generic products.

3

Products Overview

Branded Pharmaceuticals

The following table displays the revenues from external customers of our Branded Pharmaceuticals segment for the years ended December 31, 2022 and 2021 (in thousands):

		2022			2021
Specialty Products:
XIAFLEX®	$	438,680	$	432,344
SUPPRELIN® LA		113,011			114,374
Other Specialty (1)		70,009			86,432
Total Specialty Products	$	621,700	$	633,150
Established Products:
PERCOCET®	$	103,943	$	103,788
TESTOPEL®		38,727			43,636
Other Established (2)		86,772			113,043
Total Established Products	$	229,442		$	260,467
Total Branded Pharmaceuticals (3)	$	851,142	$	893,617

__________

1. Products included within Other Specialty include AVEED®, NASCOBAL® Nasal Spray and QWO®.
2. Products included within Other Established include, but are not limited to, EDEX®.
3. Individual products presented above represent the top two performing products in each product category for the year ended December 31, 2022 and/or any product having turnover in excess of $25 million during any completed quarterly period in 2022 or 2021.

Specialty Products Portfolio

Endo commercializes a number of products within the market served by specialty distributors and specialty pharmacies and in which healthcare practitioners can purchase and bill payers directly (the buy and bill market). Our current offerings primarily relate to the following areas: (i) urology treatments, which currently focus mainly on PD and testosterone replacement therapies (TRT) for hypogonadism; (ii) orthopedics treatments, which currently focus on DC; and (iii) pediatric endocrinology treatments, which currently focus on central precocious puberty (CPP). Key product offerings in this portfolio include the following:

• XIAFLEX®, which is a non-surgical treatment for both DC (for adult patients with an abnormal buildup of collagen in the fingers that limits or disables hand function) and PD (for adult men with a collagen plaque and a penile curvature deformity of thirty degrees or greater at the start of therapy).
• SUPPRELIN® LA, which is a soft, flexible 12-month hydrogel implant based on our hydrogel polymer technology that delivers histrelin acetate, a gonadotropin-releasing hormone agonist, and is indicated for the treatment of CPP in children.
• AVEED®, which is a novel, long-acting testosterone undecanoate for injection for the treatment of hypogonadism that is dosed only five times per year after the first month of therapy.
• NASCOBAL® Nasal Spray, which is a prescription nasal spray used as a supplement to treat vitamin B12 deficiency.

This portfolio has also included QWO® (collagenase clostridium histolyticum-aaes), an injectable treatment for moderate to severe cellulite in the buttocks of adult women launched in March 2021. However, in December 2022, the Group announced it would be ceasing the production and sale of QWO® in light of market concerns about the extent and variability of bruising following initial treatment as well as the potential for prolonged skin discoloration.

Established Products Portfolio

This portfolio's current treatment offerings primarily relate to the following areas: (i) pain management, including

products in the opioid analgesics segment and for the treatment of pain associated with post-herpetic neuralgia, and (ii) urology, focusing mainly on the treatment of hypogonadism. Key product offerings in this portfolio include, among others, the following:

• PERCOCET®, which is an opioid analgesic approved for the treatment of moderate to moderately-severe pain.
• TESTOPEL®, which is a unique, long-acting implantable pellet indicated for TRT in conditions associated with a deficiency or absence of endogenous testosterone.

4