Endo International Explained

Endo International plc
Type:	public liability company
Predecessor:	Endo Pharmaceuticals Inc. (before the 2014 tax inversion to Ireland)
Hq Location:	(Legal) Dublin, Ireland (Operational) Malvern, Pennsylvania, United States.
Num Employees:	3103 (2021)
Industry:	Pharmaceutical
Footnotes:	Financials

Endo International plc is an American Irish-domiciled generics and specialty branded pharmaceutical company that generated over 93% of its 2017 sales from the U.S. healthcare system. While Endo's management, operations, and customers are almost exclusively U.S.–based, in 2013 Endo executed a corporate tax inversion to Ireland to avoid U.S. corporate taxes on their U.S. drug sales, and to avail of Ireland's corporate tax system.^{[1] [2] [3]}

Endo net sales by region (2017)^[4]

Region	Sales ($ m)	Distribution (%)
U.S. Generic	2,281.0	65.8
U.S. Branded	957.5	27.6
Non-U.S. / International	230.3	6.6
Total	3,468.8	100.0

Predecessors and History

In 1920, Intravenous Products of America was incorporated as a privately owned pharmaceutical business operating in New York. By 1935 it had changed its name to Endo Products.^[5] The product line focused on medication for the treatment of pain (e.g. Percodan), a focus which continued during its acquisition by DuPont in 1969 (e.g. Percocet).^[6]

Endo Pharmaceuticals Holdings was created as a result of a $277 million management buyout of the division from DuPont Merck in 1997, led by Carol Ammon.^[7] Through the merger with Algos, it changed name again to Endo Pharmaceuticals Holdings Inc. and began trading as a public company.^[8]

In 2012 shareholders voted to again change name to Endo Health Solutions, with Endo Pharmaceuticals becoming a segment of the business.^[9] Through the 2014 acquisition of Paladin Labs and subsequent corporate restructuring, Endo International plc was formed.

2022-3 Bankruptcy Proceedings

In 2022, Endo's stock fell below $1 as the company faced restructuring of its $8 billion of debt.

On August 17, 2022 Endo International Plc filed for Chapter 11 bankruptcy protection after reaching a $6 billion deal with some of its creditors.^[10] That related to opioid litigation in the US and a $6 billion deal with creditors, including for settling lawsuits.^[11]

The United States Department of Justice has objected to the plans, claiming they violate bankruptcy law.^[12]

Acquisitions

• 1999: Predecessor Endo Pharmaceuticals Holdings agreed to buy Algos Pharmaceutical Corporation, in a bid to gain additional products for the painkiller market.^[13]
• 2006: Endo acquired RxKinetix, leading to a fall in profits.^{[14] [15]}
• 2009: Endo bought Indevus Pharmaceuticals to diversify into endocrinology and oncology.^[16] The company entered the male hypogonadism market later in 2010 with Fortesta 2% gel.
• 2010: Endo acquired generic manufacturer Qualitest Pharmaceuticals for $1.2 billion
• 2011: Endo acquired medical device manufacturer American Medical Systems for more than $2 billion^{[17] [18]}
• 2013: Endo agreed to purchase Paladin Labs Inc for about $1.6 billion to gain access to the Canadian market as well as expand into emerging markets.^{[19] [20]} The acquisition was subsequently used via Canadian tax laws to execute a corporate tax inversion to Ireland.^[21] In July 2015, The Wall Street Journal noted Endo was using Ireland's lower tax rate to acquire U.S.–based life sciences firms and relocate them to Ireland's tax regime (i.e. they could afford to pay more to acquire U.S. competitors).^[22]
• 2014: In early 2014, Endo sought to acquire NuPathe, a speciality pharmaceutical developer, for $105 million.^{[23] [24]} However, Teva prevailed in this acquisition with a substantially higher bid.^{[25] [26]} In September 2014, Endo offered to buy Auxilium Pharmaceuticals and its portfolio in a then rejected offer,^[27] before acquiring the company the following month in a deal valued at $2.6 billion.^[28] This expanded Endo's portfolio to include 12 additional products, including a variery of testosterone preparations, and Xiaflex (a treatment for Peyronie's disease)^{[29] [30]} In the same year they also acquired Dava Pharmaceuticals.^{[31] [32]}
• 2015: Endo acquired the specialty generics and sterile injectables company Par Pharmaceutical for $8.05 billion.^{[33] [34]} The FTC required divestments of assets to Rising Pharmaceuticals for the deal to go through.^[35]
• 2018-19: Endo announced and then terminated a deal to acquire Somerset Therapeutics^[36]
• 2020: Endo acquired BioSpecifics Technologies for more than $500 million^{[37] [38]}

Lawsuits

Mesh

After facing lawsuits over its production of vaginal mesh implants, Endo shut down its production in 2016 to avoid further litigation^[39] It had set aside more than $2.6 billion to payments for such cases.^[40]

Opioids

Endo is one of the companies named in lawsuits by the states of Ohio,^[41] Missouri and Mississippi^[42] as responsible for the US opioid epidemic. Its 10-K statement indicates that a majority of the company's US revenue in 2016 was derived from the sale of prescription pain killers, predominantly opioids.^[43]

On June 8, 2017, the U.S. Food and Drug Administration (FDA) released a press statement in which it announced that it requested Endo to withdraw its opioid drug, oxymorphone hydrochloride (Opana ER), from the market. Opana has been linked to outbreaks of HIV, hepatitis C and serious blood disorders.^[44] It was the first time that the FDA had "taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse."^[45]

In 2021, New York Attorney General Letitia James filed a lawsuit against Endo and several other opioid manufacturers for their alleged contribution to the opioid epidemic in New York.^[46]

As part of Endo's 2022 bankruptcy proceedings, it agreed to spend more than $500 million settling opiod relating lawsuits. These proceedings now require Endo to turn over all court documents related to its role in the opioid crisis for publication in a public online archive.^{[47] [48] [49]}

In 2024, Endo agreed to a civil settlement of $464.9 Million to resolve its civil liability under the federal False Claims Act by unlawfully promoting Opana ER, a dangerous opioid drug that was removed from the market by Endo at the FDA’s request.^[50]

Non-profit funding

Endo Pharmaceuticals at various times was a significant funder of the American Pain Foundation, which has been accused of producing misleading and biased materials relating to opiod prescribing.^{[51] [52]} APF shut down in 2012 after the United States Senate Committee on Finance began an investigation into the relationships between narcotic manufacturers and pain advocacy organisations.^{[53] [54]} APF cited "irreparable economic circumstances" in its decision to close.^[55]

Testosterone

In 2018, Endo paid $200 million to settle over 1,200 lawsuits related to its testosterone replacement therapy, Testim, and its undisclosed side effects.^{[56] [57] [58]}

See also

• Corporate tax inversions
• Ireland as a tax haven

References

Additional references

• Form 10-K 2021: Endo International Plc, Form 10-K for fiscal year ended December 31, 2021 . 1 March 2022 . . 4 February 2023 . XBRL . .

Notes and References

1. Web site: 1 March 2017 . Tracking Tax Runaways . 4 February 2023 . . Corporate Expatriates: See the Data.
2. Web site: Houlder . Vanessa . Boland . Vincent . Politi . James . 29 April 2014 . Tax avoidance: The Irish inversion . Financial Times.
3. Web site: George . John . 11 March 2014 . Endo re-incorporates in Ireland to save millions in taxes . . Blog post . The company was able to legally reincorporate in Ireland only after completing a deal to buy a foreign-based company using at least 20 percent of its own stock. Endo met that threshold by buying Paladin Labs, a Canadian drug manufacturer, for $1.6 billion in a deal that was finalized Feb. 28..
4. Web site: SEC Form 10-K: Endo Pharma public limited company . . 62 . Results of Operations: Net Sales.
5. Web site: Endo International and American Medical Systems - History & Products . 2023-10-01 . Drugwatch.com . en.
6. News: Hepp . Christopher K. . 2010-09-29 . Endo buying generic drug maker for $1.2 billion . 2023-10-01 . The Philadelphia Inquirer . en.
7. News: Schneiderman. R.M.. Ammon Exits Endo. Forbes. 9 April 2007. en.
8. Web site: Endo Pharma, Algos merger finalized - Pharmaceutical industry news . 2023-10-01 . www.thepharmaletter.com.
9. Web site: Endo Health Solutions Inc. Announced as New Name for Endo Pharmaceuticals Holdings Inc. .
10. News: Nidumolu. Jahnavi . Kalia . Shubham . August 17, 2022 . Endo files for bankruptcy as U.S. opioid litigation drags . Reuters . September 12, 2022 .
11. News: Taylor . Phil . 2022-08-18 . Endo files for bankruptcy as it agrees opioid settlement . live . 2024-06-26 . PharmaPhorum.
12. News: Knauth . Dietrich . 2023-07-26 . Bankrupt Endo says US government objections imperil $600 million in opioid settlements . en . Reuters . 2023-10-01.
13. News: 1999-11-30 . COMPANY NEWS; ENDO PHARMACEUTICALS AGREES TO ACQUIRE ALGOS . en-US . The New York Times . 2023-10-01 . 0362-4331.
14. News: Linda Loyd . 2007-02-22 . Acquisition, other charges lead Endo to 80% quarterly profit drop . 2023-10-01 . The Philadelphia Inquirer . en.
15. Web site: 2006-10-13 . RxKinetix Subsumed by Endo Pharmaceuticals . 2023-10-01 . GEN - Genetic Engineering and Biotechnology News . en-US.
16. News: 2009-01-06 . Endo to buy Indevus . The Boston Globe . Associated Press . 2009-06-28.
17. Web site: cmsadmin . 2011-06-20 . Endo Pharma Acquires American Medical Systems . 2023-10-01 . Pharmaceutical Technology . en-US . 2023-10-07 . https://web.archive.org/web/20231007001145/https://www.pharmaceutical-technology.com/uncategorized/news122327-html/ . dead .
18. News: 2011-04-11 . UPDATE 2-Endo to buy American Medical Systems for about $2.6 bln . en . Reuters . 2023-10-01.
19. News: Rubin . Ben Fox . 5 November 2013 . Endo Health to Buy Paladin Labs for $1.6 Billion . The Wall Street Journal .
20. News: November 5, 2013 . Endo Health to Buy Specialty Drug Maker for $1.6 Billion . The New York Times Dealbook .
21. Web site: 5 November 2013 . Endo buys Canada's Paladin to counter sliding sales . Reuters . The complex deal structure will create a new Irish holding company, which will own both Endo and Paladin, to take advantage of Ireland's low tax rates..
22. Web site: Liz Hoffman . 7 July 2015 . The Tax Inversion Wave Keeps Rolling . . Horizon and other inverted companies are using their new, lower tax rates to turbocharge corporate takeovers. Applying those rates, often in the midteens, to profits of companies in the U.S., with a federal corporate rate of 35%, can yield extra savings on top of those traditionally wrung from mergers. Moreover, unlike the U.S., Ireland and most other countries, only tax profits earned in-country, giving companies the freedom and incentive to shift income to still-lower-tax jurisdictions..
23. . January 15, 2014 . Endo to Purchase NuPahte for $150M+ . News: Industry Watch . . 34 . 2 . 10.
24. News: 2013-12-16 . Endo Health to acquire Nupathe for $105 million . en . Reuters . 2023-10-01.
25. News: February 15, 2014 . Teva Outbids Endo, Acquires NuPathe for $144M+ . 34 . 10 . . 4 . News: Industry Watch . paper.
26. News: Wasserman . Emily . 2014-01-21 . Endo Merger Agreement with NuPathe Terminated .
27. News: 2014-09-17 . Endo offers to buy Auxilium Pharma for about $2.2 billion . en . Reuters . 2023-10-01.
28. News: 2014-10-09 . Auxilium Pharma accepts Endo's buyout offer, drops QLT deal . en . Reuters . 2023-10-01.
29. News: 2014-10-09 . Endo bolsters men's healthcare business with Auxilium deal . en . Reuters . 2023-10-01.
30. News: Wasserman . Emily . Oct 9, 2014 . Endo To Acquire Auxilium Pharmaceuticals In A Cash And Stock Transaction For Approximately $2.6 Billion . Fierce Pharma .
31. Web site: Mekala . 2014-06-24 . Endo to acquire Dava Pharmaceuticals for $575m . 2023-10-01 . Pharmaceutical Technology . en-US.
32. News: 2014-06-24 . Endo to buy DAVA Pharma for $575 million . en . Reuters . 2023-10-01.
33. News: Bray . Chad . 18 May 2015 . Endo International to Pay $8.05 Billion for Par Pharmaceutical . The New York Times .
34. News: 2015-05-18 . Endo pushes further into generics with $8 billion Par Pharma buy . en . Reuters . 2023-10-01.
35. Web site: 2015-09-25 . FTC Requires Divestitures in Connection with Endo International plc's Proposed Acquisition of Par Pharmaceuticals, Inc. . 2023-10-01 . Federal Trade Commission . en.
36. Web site: Palmer . Eric . 2018-02-28 . Endo terminates $190M deal for sterile injectable player .
37. Web site: Owens . Jacob . 2020-10-19 . BioSpecifics to merge with Endo in $540M deal . 2023-10-01 . Delaware Business Times . en-US.
38. News: DiStefano . Joseph N. . 2020-10-19 . A cellulite-fighting drug is a big part of Malvern-based Endo's plan to buy BioSpecifics for $658 million . 2023-10-01 . The Philadelphia Inquirer . en.
39. News: 2018-03-01 . Endo to terminate vaginal mesh manufacturing to avoid litigation . Fierce Biotech . unfit . https://web.archive.org/web/20170707142509/http://www.fiercebiotech.com/medical-devices/endo-to-terminate-vaginal-mesh-manufacturing-to-avoid-litigation/ . 2017-07-07.
40. News: 2017-08-07 . Endo Sets Aside $775 Million to Settle Remaining Mesh Lawsuits . en . Bloomberg.com . 2023-10-01.
41. News: Dwyer. Colin. Ohio Sues 5 Major Drug Companies For 'Fueling Opioid Epidemic'. NPR Online. 31 May 2017. en.
42. News: Raymond. Nate. Missouri sues opioid manufacturers, joining two other U.S. states. Reuters. 21 Jun 2017. en.
43. Web site: Eondo Pharmaceuticals, FORM 10-K. 31 Dec 2016. en.
44. News: F.D.A. Asks Drug Maker to Stop Selling a Dangerous Opioid. The New York Times . 8 June 2017 . 2018-11-18. en. Grady . Denise .
45. June 8, 2017 . FDA requests removal of Opana ER for risks related to abuse . Press release . FDA.
46. Web site: 2021-06-26. Johnson & Johnson agrees to pay $230 million to settle N.Y. opioid case. 2021-07-01. STAT. en-US.
47. News: Fernandez . Bob . 2022-11-22 . Malvern opioid maker Endo to be monitored by Obama's former drug czar for $25K a month . 2023-10-01 . The Philadelphia Inquirer . en.
48. Web site: Schneider . Staci . 2023-06-21 . The Role of the Attorney General in the Opioid Crisis . 2023-10-01 . National Association of Attorneys General . en-US.
49. Web site: 2022-08-17 . Pennsylvania among 7 states to reach $450 million settlement with opioid manufacturer Endo - CBS Philadelphia . 2023-10-01 . www.cbsnews.com . en-US.
50. Web site: Opioid Manufacturer Endo Health Solutions Inc. Agrees to Global Resolution of Criminal and Civil Investigations into Sales and Marketing of Branded Opioid Drug . www.justice.gov . U.S. Department of Justice . 5 June 2024 . en . 29 February 2024.
51. Web site: Lurie . Julia . Unsealed documents show how Purdue Pharma created a "pain movement" . 2023-10-01 . Mother Jones . en-US.
52. Web site: Weber, Charles . Ornstein, Tracy . 2011-12-23 . The Champion of Painkillers . 2023-10-01 . ProPublica.
53. Web site: Weber, Charles . Ornstein, Tracy . 2012-05-08 . American Pain Foundation Shuts Down as Senators Launch Investigation of Prescription Narcotics . 2023-10-01 . ProPublica.
54. Web site: Warner . Gregory . 2012-05-09 . Major pain-advocacy group dissolves . 2023-10-01 . Marketplace . en-US.
55. Web site: APF Updates . https://web.archive.org/web/20160306165433/http://www.painfoundation.org/ . 2016-03-06.
56. Web site: Endo to Settle 1,300 Testosterone Lawsuits for $200 Million . 2023-10-01 . Drugwatch.com . en.
57. News: 2018-02-23 . Endo, Glaxo to Settle Suits Over Testosterone Drug . en . Bloomberg.com . unfit . 2023-10-01 . https://web.archive.org/web/20180223231637/https://www.bloomberg.com/news/articles/2018-02-23/endo-glaxo-to-settle-suits-over-testosterone-replacement-drugs? . 2018-02-23.
58. News: Sagonowsky . Eric . 2018-06-12 . After setting aside $200M, Endo settles 1,300 testosterone liability lawsuits . Fierce Pharma .