| Mallinckrodt Pharmaceuticals plc | |
| Industry: | Pharmaceutical |
| Type: | Public |
| Hq Location: |
|
| Num Employees: | 2,800 (2023) |
| Revenue: | (2023)[1] |
| Assets: | (2023) |
| Equity: | (2023) |
Mallinckrodt Pharmaceuticals plc is an American-Irish domiciled manufacturer of specialty pharmaceuticals (namely, adrenocorticotropic hormone), generic drugs and imaging agents.[2] In 2017, it generated 90% of its sales from the U.S. healthcare system. While Mallinckrodt is headquartered in Ireland for tax purposes, its operational headquarters are in the U.S.[3] Mallinckrodt's 2013 tax inversion to Ireland drew controversy when it was shown Acthar was Medicaid's most expensive drug.
Mallinckrodt acquires (for repricing), manufactures, and distributes products used in diagnostic procedures and in the treatment of pain and related conditions. This includes the acquisition, manufacture, and distribution of specialty pharmaceuticals, active pharmaceutical ingredients, contrast products, and radiopharmaceuticals. The company employed 5,500 and had net sales of $3.2 billion in 2017, of which $2.9 billion was from the U.S. healthcare system.
The company has been implicated as a major contributor to the prescription opioid scandal around the over-prescription of oxycodone in the United States.[4]
In 1867, the three Mallinckrodt brothers, Gustav, Otto and Edward Sr., founded G. Mallinckrodt & Co. in St. Louis.[5] The Mallinckrodt family had immigrated from Germany. Otto and Edward both temporarily returned to Germany, then the leader in chemical research and education, for advanced training.[6] Brothers Gustav and Otto died in the 1870s, leaving Edward (1845–1928) in sole charge of the family business. Mallinckrodt Chemical Works was incorporated 15 years later, in 1882.
By 1898, the company had established itself as a pharmaceuticals supplier and in 1913 became the first to introduce barium sulfate as a contrast medium for x-rays.[5] In part due to early success in production of radiology agents, and at the behest of surgeon Evarts Graham, Edward Mallinckrodt Sr. assigned one of the company's top chemists to collaborate in developing the first radiographic agent for gallbladder and bile duct imaging.[7]
In April 1942 Edward Mallinckrodt was approached by a contingent from the Metallurgical Laboratory of the Manhattan Project, particularly by Arthur Holly Compton.[8] Compton urgently needed a source of refined uranium. The chemical company already worked with ether, which could theoretically be used in a purifying process but which posed its own handling risks. With extreme haste and with tight security restrictions, Mallinckrodt developed a novel technique from theoretical concept, to experiment, to full production. The company submitted test materials by mid-May, supplied the material for the first self-sustaining reaction in December, and had satisfied the project's entire order of the first sixty tons before the contract with the government was even signed.
From 1942 to 1957, Mallinckrodt processed uranium ore into weapons-grade uranium at a factory north of downtown St. Louis.[9] Nuclear waste from the factory and other locations was buried in steel drums at a 21.7-acre site near Lambert Field.[10] Radioactive waste from the site seeped into Coldwater Creek.[11] The area was designated a Superfund site by the Environmental Protection Agency in 1989.[12] [13]
The company issued public shares in 1954.[14]
Throughout its history, Washington University in St. Louis has received a large number of donations from the Mallinckrodt family and corporation, including a posthumous endowment by Edward Mallinckrodt Jr. on behalf of his father to the Washington University School of Medicine Radiology Department resulting in the creation of the Mallinckrodt Institute of Radiology.[15] Both Edward Mallinckrodt Sr. and Jr. served as members of the Washington University Board of Trustees. Washington University in St. Louis' student union building and performing arts building was renamed the Mallinckrodt Center in 1976.[16]
In 2018, Mallinckrodt partnered with the Washington University School of Medicine with funding of up to $10 million over five years to support research projects that show promise in developing new drugs for treating rare diseases.[17]
The elder Edward also made significant donations to his alma mater, Harvard University, and to the St. Louis College of Pharmacy.[18]
See also: Corporation tax in the Republic of Ireland#Corporate tax inversions.
In 2013, Mallinckrodt executed a corporate tax inversion to Ireland to avoid U.S. corporate taxes, by acquiring Irish-based Cadence Pharma for $1.3 billion.[19] This was despite the fact that almost all of Mallinckrodt's revenues come from the U.S. market (see table below). In 2015, Mallinckrodt was one of several U.S. tax inversions that The Wall Street Journal reported to be using a lower tax-platform to acquire further U.S. pharmaceutical firms, such as the $5.6 billion acquisition of Questor in 2014.[20] In December 2015, The Irish Times reported the CEO as saying that "It'd have to be a pretty dramatic change to the US tax code" for Mallinckrodt to return to the U.S., and that "We're already foreign domiciled, so we may as well take full advantage of it".[21]
In February 2018, Mallinckrodt told the Wall Street Journal that it would get a $450 to $500 million tax credits from the Tax Cuts and Jobs Act of 2017 (TCJA), but that some of these benefits would be offset by the anti-inversion provisions of the TCJA.[22] In April 2018, Mallinckrodt's Irish tax inversion came under further scrutiny when it was revealed that Mallinckrodt's main drug, Acthar, was one of the most expensive drug-related expenditures for the U.S. Medicare programme.[23]
| Region | Sales ($ m) | Distribution (%) | |
|---|---|---|---|
| U.S. | 2,899.0 | 90.3 | |
| Europe, Middle East and Africa | 242.3 | 7.5 | |
| Other | 80.3 | 2.2 | |
| Total | 3,211.6 | 100.0 |
In December 2012, The New York Times, in an article on Mallinckrodt's main drug H.P. Acthar Gel, reported: "How the price of this drug rose so far, so fast is a story for these troubled times in American health care—a tale of aggressive marketing, questionable medicine and, not least, out-of-control costs".[25] In January 2017, the Financial Times reported that Mallinckrodt had made a settlement of $100 million with the U.S. Federal Trade Commission (FTC) in relation to antitrust probes on Acthar and quoted the FTC as saying: "Questcor [Mallinckrodt's subsidiary] took advantage of its monopoly to repeatedly raise the price of Acthar, from $40 per vial in 2001 to more than $34,000 per vial today – an 85,000 percent increase".[26] The city of Rockford, Illinois, is now suing Mallinckrodt and pharmacy benefit management company Express Scripts for their failure to reduce Acthar's price.[27]
In May 2017, the Wall Street Journal reported that U.S. investor Jim Chanos accused Mallinckrodt in relation to Acthar of being a "one-product company",[28] and the Irish Times quoted Chanos on Bloomberg stating that a "murky alliance" had developed between Mallinckrodt and distributor Express Scripts, who is the sole distributor of Acthar, and that "Acthar is the epitome of excessive drug prices".[29] In September 2017, the Journal of the American Medical Association (JAMA) published research showing that Acthar was one of the most expensive drugs in the U.S. Medicaid and Medicare system, but that most sales of Acthar were "driven in part by a relatively small group of doctors who were prescribing it heavily", and that alternatives at one-fiftieth of the price of Acthar were available.[30] [31]
In April 2018, a whistleblower lawsuit claimed Acthar, which had never passed a modern FDA process as Acthar had been available for 60 years and was thus passed under FDA "grandfathering" rules, had an unknown formulation and efficacy. The lawsuit claimed that this situation would not be sustainable without the support of Express Scripts.[32]
A whistleblower filed a qui tam action in 2018 alleging that Mallinckrodt failed to pay the correct Medicaid rebates for Acthar in violation of the federal and state False Claims Acts.[33] Medicaid Rules required Mallinckrodt to pay back the amount it had raised the price of Achtar above inflation.[34] To avoid meeting its increased rebate obligations, Mallinckrodt began reporting Acthar’s base AMP as if it had been approved in 2010 (after the enormous price increases).[35]
In October 2020, Mallinckrodt filed for bankruptcy, which stayed the pending False Claims Act case.[36] On March 2, 2022, the bankruptcy court confirmed Mallinckrodt’s plan of reorganization, which included the settlement of the whistleblower's lawsuit for $234 million.[37]
A US Drug Enforcement Administration (DEA) database tracking every opioid pill sold in the United States from 2006 through 2012 was made public in 2019. The database "attributed the vast majority of the 76 billion opioid pills produced and shipped from 2006 through 2012 to three companies", one of which was SpecGx, a subsidiary of Mallinckrodt. In those years SpecGx supplied 28.9 billion oxycodone pills, more than 80 for each person in the United States, and over 2 billion pills just in Florida.
In 2011 the DEA complained to Mallinckrodt about the problem of excessive prescription opioid shipments to pharmacies. DEA officials showed the company the hundreds of millions of doses of oxycodone it was shipping to distributors and the correspondingly high number of arrests being made for oxycodone possession and sale in those areas. Negotiations between the DEA and Mallinckrodt ensued, and in 2017 Mallinckrodt paid a $35 million fine to settle DEA complaints it did not adequately address suspicious opioid orders, acknowledging "certain aspects of Mallinckrodt's system to monitor and detect suspicious orders did not meet" DEA standards.
Mallinckrodt announced in April 2019 a plan to change its name to Sonorant Therapeutics, and spin off "Mallinckrodt Inc." as a separate company for its generics business. Legal liabilities that result from opioid litigation would "remain with Mallinckrodt Inc. or its subsidiaries following the separation."
In February 2020, the company struck a $1.6 billion deal with Florida and dozens of other states to settle lawsuits over its role in the US opioid crisis.[38]
In October 2020, Mallinckrodt filed for Chapter 11 bankruptcy protection while facing more than $1 billion in costs from lawsuits over its role in fueling the opioid crisis.[39]
On June 2, 2023, Mallinckrodt announced that they would be considering a second Chapter 11 bankruptcy protection filing after lenders of the company raised concerns over an upcoming $200 million payment related to opioid-related litigation that was due in the coming weeks.[40] However, on June 16, Mallinckrodt got an extension on their $200 million payment with a new due date of June 23, 2023.[41] On June 23, the day the payment was supposed to be due, Mallinckrodt got their payment due date extended for the second time to June 30, 2023.[42] It later got delayed to July 7, 2023, and again to July 14, 2023.[43]
On July 11, 2023, Mallinckrodt was sued for allegedly misleading investors for misrepresenting its financial strength before missing payments to opioid victims and bond holders.[44] On July 14, Mallinckrodt's $200 million opioid payment was once again extended to July 21.[45] On July 17, it was extended yet again to August 15.[46]
On July 27, 2023, Mallinckrodt announced that they were in negotiations to completely avoid paying the opioid payment to victims. If this plan turns out successful, victims of the opioid payment could lose up to a maximum of $1 billion, and the money could end up going to funds and investors instead.[47] On August 15, 2023, Mallinckrodt announced that they were preparing to file for their second Chapter 11 bankruptcy filing in three years after failing to make scheduled payments to its lenders and opioid creditors since June, sighting numerous short-term extensions to its payment within the last two months. Mallinckrodt is currently in negotiations to establish a restructuring support agreement with its stakeholders, and the payment was also extended once again to next week. Mallinckrodt stated that there would be no guaranteed recovery for holders of its ordinary equity shares in the eventuality of a bankruptcy filing .[48]
On August 23, after losing approximately 92% of their stock value in 2023, Mallinckrodt officially announced their intention to file for Chapter 11 protection within the coming days in order to reduce the amount of long-term debt it owes to victims of the opioid crisis and cut its debt obligations. The company has also entered into a new restructuring agreement with its creditors and an opioid victims trust.[49] On August 28, 2023, Mallinckrodt and some of its affiliated debtors filed a voluntary petition under Chapter 11 of the United States Code in the United States District Court for the District of Delaware for the second time in three years in effort to dramatically cut its debt load and reduce its sweeping opioid settlement.[50] Immediately after the announcement, the NYSE halted Mallinckrodt's stock, and its stock was delisted from the New York Stock Exchange soon thereafter, and began trading on OTC Markets.[51]
On November 14, 2023, Mallinckrodt reduced its total funded debt by approximately $1.9 billion after winning approval for its bankruptcy plan to ample liquidity to execute strategic priorities back in October, and announced that it has completed its second Chapter 11 reorganization and has exited bankruptcy. Ownership of Mallinckrodt will be handed over to lenders and bondholders and all remaining equity sales would end.[52]
In December 2018 the company announced it will spin off its specialty generics business into a separate publicly traded company, initially owned by existing Mallinckrodt shareholders. The division generated $840 million in 2017 and the deal will also include constipation drug, Amitiza. Chief Financial Officer, Matthew Harbaugh, will head the new company which will retain the Mallinckrodt name. The remaining business of specialty branded products will be renamed and led by current Chief Executive Officer, Mark Trudeau.[75] Legal liabilities that result from opioid litigation are expected to be the responsibility of Mallinckrodt Inc. or its subsidiaries following the separation.
Mallinckrodt has two main product lines.[76]
In the fourth quarter of 2014, Specialty Pharmaceuticals accounted for 74% of net sales. Key specialty pharmaceutical products include:
Mallinckrodt specializes in producing generic controlled substances and compounds. Their products include:[80]
Medical imaging products include Optiray (ioversol injection), an iodide based contrast medium for CT scans, and Optimark (gadoversetamide injection) a Gadolinium-Based Contrast Agent used in magnetic resonance imaging (MRI) of the brain or liver.
As of 1988, Mallinckrodt was the only company in the U.S. that is allowed to receive cocaine, which is sold as a prescription drug for use in hospitals as a local anesthetic by eye and ear, nose and throat (ENT) doctors.[82]
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