Endo International : 2020 Irish Statutory Accounts
05/07/2021 | 02:08pm EDT
ENDO INTERNATIONAL PUBLIC LIMITED COMPANY
Directors' Report and Financial Statements For the Year Ended December 31, 2020
ENDO INTERNATIONAL PLC
TABLE OF CONTENTS
Directors and Other Information
Statement of Directors' Responsibilities
Independent Auditors' Report to the Members of Endo International plc
Consolidated Profit and Loss Account
Consolidated Statement of Comprehensive Income (Loss)
Consolidated Balance Sheet
Consolidated Statement of Cash Flows
Consolidated Reconciliation of Shareholders' Funds
Notes to Consolidated Financial Statements
Company Reconciliation of Shareholders' Funds
Company Balance Sheet
Notes to Company Financial Statements
DIRECTORS AND OTHER INFORMATION
Mark G. Barberio (United States)
Paul Campanelli (United States)
Blaise Coleman (United States)
Shane M. Cooke (Ireland)
Nancy J. Hutson, Ph.D. (United States)
Michael Hyatt (United States)
Roger H. Kimmel (United States)
William P. Montague (United States)
M. Christine Smith, Ph.D. (United States)
Matthew Maletta (United States)
North Wall Quay,
Bank of America,
2 King Edward Street,
London EC1A 1HQ.
Chartered Accountants and
Statutory Audit Firm,
One Spencer Dock,
North Wall Quay,
For the Year Ended December 31, 2020
The directors present their report and audited Consolidated Financial Statements for the year ended December 31, 2020.
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 are traded on the NASDAQ Global Select Market (Nasdaq) under the ticker symbol "ENDP." 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 acquisition of products and 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 "RESULTS OF OPERATIONS." Across all of our reportable business segments, we generated total turnover of $2.90 billion, and $2.91 billion in 2020 and 2019, 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 United States (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 marketed 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., a first-to-file product refers to a generic product for which the Abbreviated New Drug Application (ANDA) containing a patent challenge (or Paragraph IV certification) to the corresponding branded product's listed patents was 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. A first-to-market product refers to a product that is the first marketed generic equivalent of a branded product 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.
The following table displays the turnover from external customers of our Branded Pharmaceuticals segment for the years ended December 31, 2020 and 2019 (in thousands):
Other Established (2)................................................................................................................
Total Established Products..........................................................................................................
Total Branded Pharmaceuticals (3).............................................................................................
(1) Products included within Other Specialty are NASCOBAL® Nasal Spray and AVEED®.
(2) Products included within Other Established include, but are not limited to, EDEX® and LIDODERM®.
(3) Individual products presented above represent the top two performing products in each product category for the year ended December 31, 2020 and/or any product having turnover in excess of $100 million during any of the years ended December 31, 2020 or 2019 or $25 million during any quarterly period in 2020 or 2019.
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 two distinct areas: (i) urology treatments, which focus mainly on Peyronie's disease (PD) and testosterone replacement therapies (TRT) for hypogonadism and (ii) orthopedics/pediatric endocrinology treatments, which focus on Dupuytren's contracture (DC) and 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.
NASCOBAL® Nasal Spray, which is a prescription nasal spray used as a supplement to treat vitamin B12 deficiency.
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.
Additionally, QWO® was approved by the FDA in July 2020 for the treatment of moderate to severe cellulite in the buttocks of adult women. During 2020, we put in place a U.S. aesthetics commercial team and the capabilities that enabled us to launch QWO® in March 2021.
Established Products Portfolio
This portfolio's current treatment offerings primarily relate to two distinct 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.
Endo International plc published this content on 07 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 May 2021 18:07:02 UTC.