Mallinckrodt

{{short description|American-Irish domiciled pharmaceutical}}

{{Other uses}}

{{Infobox company

| name = Mallinckrodt Pharmaceuticals plc

| logo = File:Mallinckrodt logo.png

| image =

| image_caption =

| industry = Pharmaceutical

| predecessor =

| ISIN = {{ISIN|sl=n|pl=y|IE00BBGT3753}}

| type = Public

| traded_as = {{Unbulleted list|{{OTC Pink|MNKTQ}}|{{NYSE was|MNK}}}}

| founded = {{Start date and age|1867}}

| key_people = {{Unbulleted list| Paul Bisaro (chairman)|Siggi Olafsson (CEO)| Bryan Reasons (CFO)}}

| hq_location = *Dublin, Ireland (legal)

| revenue = {{Increase}} {{US$|1.98 billion}} (2024){{cite web|url=https://www.sec.gov/ix?doc=/Archives/edgar/data/0001567892/000156789225000010/mnk-20241227.htm|title=2024 Annual Report (Form 10-K) |date=March 13, 2025 |publisher=U.S. Securities and Exchange Commission}}

| operating_income = {{nowrap| {{Increase}} {{US$|90.2 million}} (2024)}}

| net_income = {{nowrap| {{Increase}} {{US$|478 million}} (2024)}}

| assets = {{Decrease}} {{US$|3.30 billion}} (2024)

| equity = {{Increase}} {{US$|1.65 billion}} (2024)

| num_employees = 2,700 (2024)

| website = {{URL|mallinckrodt.com}}

}}

Mallinckrodt Pharmaceuticals plc is an American-Irish domiciled manufacturer of specialty pharmaceuticals (namely, adrenocorticotropic hormone), generic drugs and imaging agents.{{cite web | title = Mallinckrodt | url = https://online.wsj.com/article/BT-CO-20130701-703560.html | work = The Wall Street Journal | date = 1 July 2013 | url-access = subscription | access-date = 14 March 2017 | archive-date = 10 December 2013 | archive-url = https://web.archive.org/web/20131210064932/http://online.wsj.com/article/BT-CO-20130701-703560.html | url-status = dead }} 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.{{cite web|url=https://www.independent.ie/business/irish/mallinckrodt-agrees-deal-to-exploit-irish-tax-base-30163963.html|title=Mallinckrodt agrees deal to exploit Irish tax base|publisher=Irish Independent|date=8 April 2014|quote=Pharma firm Mallinckrodt has agreed to buy Questcor Pharmaceuticals for $5.6bn (€4bn) to add specialty drugs in the latest industry deal that moves a US company to Ireland for a lower tax rate. Mallinckrodt, with a registered headquarters in Dublin and run from Hazelwood, Missouri, will pay $86.08 a share for Anaheim, California-based Questcor.}} 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.{{Cite news | first1=Aaron C. | last1=Davis | first2=Shawn | last2=Boburg | first3=Robert | last3=O'Harrow Jr. | url=https://www.washingtonpost.com/investigations/little-known-generic-drug-companies-played-central-role-in-opioid-crisis-documents-reveal/2019/07/26/95e08b46-ac5c-11e9-a0c9-6d2d7818f3da_story.html | title=Little-known makers of generic drugs played central role in opioid crisis, records show | newspaper=The Washington Post | date= July 26, 2019}}

History

= Origins =

In 1867, the three Mallinckrodt brothers, Gustav, Otto and Edward Sr., founded G. Mallinckrodt & Co. in St. Louis.{{Cite web | title=SHSMO-St. Louis s0452 Mallinckrodt, Edward Jr. (1878–1967) | url=https://collections.shsmo.org/manuscripts/stlouis/s0452.pdf | publisher=State Historical Society of Missouri}} 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.Mercelis, Joris. [http://www.immigrantentrepreneurship.org/entry.php?rec=231 "Edward Mallinckrodt Sr."] In Immigrant Entrepreneurship: German-American Business Biographies, 1720 to the Present, vol. 3, edited by Giles R. Hoyt. German Historical Institute. Last modified March 10, 2015. 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.

File:Edward Mallinckrodt.jpg

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. 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.{{Cite journal|last=Evens|first=Ronald G.|date=2009-01-07|title=Roentgenologic Examination of the Gallbladder (Cholecystography)|journal=JAMA|volume=301|issue=1|pages=100–101|doi=10.1001/jama.2008.893|pmid=19126816|issn=0098-7484|doi-access=free}}

= Uranium processing (1942–1957) =

In April 1942 Edward Mallinckrodt was approached by a contingent from the Metallurgical Laboratory of the Manhattan Project, particularly by Arthur Holly Compton.{{cite web |last1=Ruhoff |first1=John (as told to Pat Fain) |title=The Mallinckrodt Chemical Works Story, 1962:The First 50 Critical Days |url=https://ahf.nuclearmuseum.org/wp-content/uploads/2015/04/The%20Mallinckrodt%20Chemical%20Works%20Story.pdf |website=Atomic Heritage Foundation |publisher=National Museum of Nuclear Science & History |access-date=9 December 2023}} 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.{{cite news|last1=Hartmann|first1=Ray|title=The Poisoned Children of Coldwater Creek: St. Louis' nuclear legacy may be graver than anyone knows.|url=http://www.stlmag.com/news/think-again/The-Poisoned-Children-of-Coldwater-Creek/|accessdate=January 2, 2016|work=St. Louis Magazine|date=May 22, 2013}} Nuclear waste from the factory and other locations was buried in steel drums at a 21.7-acre site near Lambert Field.{{cite news|last1=Eleftheriou-Smith|first1=Loulla-Mae|title=Coldwater Creek, St Louis: The area of Missouri under investigation after 'unusual' numbers of rare cancers found|url=https://www.independent.co.uk/news/world/americas/coldwater-creek-st-louis-the-area-of-missouri-under-investigation-after-unusual-numbers-of-rare-a6711616.html|accessdate=January 2, 2016|work=The Independent|date=October 28, 2015}} Radioactive waste from the site seeped into Coldwater Creek.{{cite news |last1=Salter |first1=Jim |title=Missouri school to close after radioactive waste report |url=https://apnews.com/article/health-education-cancer-st-louis-missouri-be4a2acec5aeeae1fff94aca76f056a1 |work=AP News |date=October 18, 2022 |language=en}} The area was designated a Superfund site by the Environmental Protection Agency in 1989.{{cite web |title=St. Louis Airport/Hazelwood Interim Storage/Futura Coatings of St. Louis, Mo |url=https://cumulis.epa.gov/supercpad/SiteProfiles/index.cfm?fuseaction=second.schedule&id=0701210 |publisher=United States Environmental Protection Agency |accessdate=March 8, 2020}}

{{cite news |last1=Kite |first1=Allison |title='Atomic Fallout': Records reveal government downplayed, ignored health risks of St. Louis radioactive waste for decades |url=https://www.muckrock.com/news/archives/2023/jul/12/st-louis-landfill-toxic-superfund/ |access-date=9 December 2023 |publisher=MuckRock Foundation |date=July 12, 2023}}

= Corporate changes =

The company issued public shares in 1954.{{cite web|url=https://www.mallinckrodt.com/about/our-story/| title= Our Story | Mallinckrodt Pharmaceuticals|language=en-US|access-date=2024-02-29}} Viewed as an attractive takeover target in the era of leveraged buyouts, Mallinckrodt was bought by Avon Products in 1982, and largely kept intact as a business entity. Just four years later it was sold to International Minerals and Chemical Corporation. After re-brandings, spin-offs and other changes of corporate identity{{cite news |last1=Steyer |first1=Robert |title=What's in a Name? Mallinckrodt Goes Back to Inc |url=https://www.newspapers.com/image/142559083/?terms=mallinckrodt%2Bchemical |access-date=10 March 2020 |publisher=St. Louis Post-Dispatch (subscription required) |date=9 September 1996}} Mallinckrodt was again sold in 2000 to Tyco International.

= Cocaine processing from Coca-Cola's coca plants =

Coca-Cola includes a coca leaf extract as an ingredient prepared by Stepan Company in Maywood, New Jersey.Benson, Drew. [http://www.washingtontimes.com/world/20040419-093635-4754r.htm "Coca kick in drinks spurs export fears"], The Washington Times, April 20, 2004. Accessed June 14, 2007. The plant is the only commercial entity in the United States authorized by the Drug Enforcement Administration to import coca leaves, which come primarily from Peru via the National Coca Company. The plant extracts the cocaine from the coca plants and sells it to Mallinckrodt for medicinal purposes.{{Cite news |url=https://www.nytimes.com/1988/07/01/business/how-coca-cola-obtains-its-coca.html|title=How Coca-Cola Obtains Its Coca |last=May|first=Clifford D.|date=1988-07-01| work=The New York Times |issn=0362-4331|access-date=2016-04-18}}

{{asof|1988}}, Mallinckrodt is 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.{{Cite web |title=Mallinckrodt Pharmaceuticals – Compounding Powders – Cocaine Hydrochloride USP CII |url=https://www.mallinckrodt.com/products/generics/compounding-powders/cocaine-hydrochloride-usp-cii/ |website=Mallinckrodt Pharmaceuticals}}

= Ties to Washington University in St. Louis =

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.{{cite web|url=http://shsmo.org/manuscripts/stlouis/s0452.pdf|title=S0452 Mallinckrodt, Edward Jr. (1878–1967) Papers, 1798–1981|website=State Historical Society of Missouri: Manuscripts|publisher=State Historical Society of Missouri|page=2|access-date=23 April 2017|archive-date=21 July 2016|archive-url=https://web.archive.org/web/20160721180214/http://shsmo.org/manuscripts/stlouis/s0452.pdf|url-status=dead}} 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.{{Cite web|url=https://wustl.edu/about/campuses/danforth-campus/mallinckrodt-center-samuel-b-edison-theatre/|title=Mallinckrodt Center|website=Washington University in St. Louis|language=en-US|access-date=2019-08-19}}

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.{{Cite web|url=https://medicine.wustl.edu/news/mallinckrodt-boosts-rare-disease-research-at-washington-university/|title=Mallinckrodt boosts rare-disease research at Washington University|date=2018-08-06|website=Washington University School of Medicine in St. Louis|language=en|access-date=2019-08-19}}

The elder Edward also made significant donations to his alma mater, Harvard University, and to the St. Louis College of Pharmacy.{{cite book |date=30 July 1908 |publisher=Pharmaceutical Age |page=131 |title=Mallinckrodt |url=https://books.google.com/books?id=mMLmAAAAMAAJ&pg=PA131 |access-date=13 March 2020}}

=Tax inversion to Ireland (2013)=

{{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.{{cite web|url=https://www.irishtimes.com/business/health-pharma/dublin-based-pharm-firm-mallinckrodt-in-5-6bn-deal-1.1753121| title=Deal-based pharm firm Mallinckrodt in $5.6 bn deal|publisher=Irish Times|date=7 April 2014}} 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.{{cite news | url=https://www.wsj.com/articles/horizon-pharma-at-the-nexus-of-taxes-and-deals-1436296946| work=The Wall Street Journal| first=Liz | last=Hoffman| date=7 July 2015 | url-access=subscription |quote=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.| title=The Tax Inversion Wave Keeps Rolling}} 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".{{cite news | url=https://www.irishtimes.com/business/health-pharma/mallinckrodt-won-t-give-up-irish-home-1.2458692 | title=Mallinckrodt won't give up Irish home | work=Irish Times | date=8 December 2015|quote=Mallinckrodt, which has a tax address in Ireland, said that it will pay a tax rate of 15 per cent to 17 per cent in 2016. That low tax rate can give the company an advantage when seeking acquisitions, though Trudeau said that’s not the primary impetus for deals.}}

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.{{cite news |url=https://www.wsj.com/articles/new-tax-law-haunts-companies-that-did-inversion-deals-1518350401| title=New Tax Law Haunts Companies That Did 'Inversion' Deals|date=11 February 2018| work=The Wall Street Journal | first1=Jonathan D. | last1=Rockoff | first2=Nina | last2=Trentmann | url-access=subscription |quote=Under the law, U.S. earnings will be taxed at 21%, down from 35%. Citing the lower rate, Mallinckrodt PLC, a drug company based in the U.K. but with about 90% of its sales in the U.S., said it expects the law to be “neutral to slightly positive.” Mallinckrodt said in recent security filing it would get a $450 million to $500 million deferred tax benefit from the lower U.S. corporate rate, which would “mostly be offset” by the new limitations on interest-expense deductions.}} 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.{{cite web |author=Linette Lopez |author-link=Linette Lopez |date=11 April 2018 |title='There's other s--- in the vial': Bombshell lawsuit claims no one knows exactly what's in a drug that's cost the government over $1 billion |url=https://www.businessinsider.com/mallinckrodt-whistleblower-lawsuit-claims-acthar-scheme-2018-4?r=US&IR=T |publisher=Business Insider |quote=A new lawsuit from a former employee at Mallinckrodt Pharmaceuticals claims exactly that. The drug in question is called Acthar. It costs about $40,000 and is mainly used to treat infantile spasms. Somehow, though, the drug has become one of the biggest drug-related expenditures for Medicare, a government health insurance program for old people. In 2015, Medicare spent $500 million on the drug.}}

class="wikitable" style="text-align:left"

|+ style="text-align: left;" |Mallinckrodt net sales by region (SEC 10-K filing, 2017){{cite web|url=http://www.mallinckrodt.com/investors/sec-filings/|title=SEC Form 10-K: Mallinckrodt public limited company|publisher=Securities and Exchange Commission|page=51|quote=Results of Operations: Net Sales}}

style="text-align:left"|Region

!style="text-align:left"|Sales ($ m)

!style="text-align:left"|Distribution (%)

U.S.2,899.090.3
Europe, Middle East and Africa242.37.5
Other80.32.2
Total3,211.6100.0

=Acthar controversy=

File:Mallinckrodt Acthar Price.png

In December 2012, The New York Times, in an article on Mallinckrodt's main drug H.P. Acthar Gel,{{efn|H.P. Acthar Gel represents a little over one-third of Mallinckrodt's sales; however, its strong profitability means that it is considered to be responsible for the bulk of Mallinckrodt's profits.}} 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".{{cite news |url=https://www.nytimes.com/2012/12/30/business/questcor-finds-profit-for-acthar-drug-at-28000-a-vial.html|title=Questcor Finds Profits, at $28,000 a Vial|author=Andrew Pollock|date=29 December 2012| work=The New York Times}} 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".{{cite web|url=https://www.ft.com/content/b51a07e0-d787-351b-8c9a-11be7369af97| title=Mallinckrodt shares fall after it announces $100m antitrust settlement|author=Jessica Dye|publisher=Financial Times|quote=Drug company Mallinckrodt saw its shares end the day down nearly 6 per cent on Wednesday after it announced it would pay $100m to resolve antitrust probes into the market for a type of drug that treats a rare infant seizure disorder and other serious medical conditions.}} The city of Rockford, Illinois, is now suing Mallinckrodt and pharmacy benefit management company Express Scripts for their failure to reduce Acthar's price.{{cite web |url=https://www.cbsnews.com/news/60-minutes-reports-prescription-drug-price-fixing-2019-05-12/7| title=60 Minutes reports: prescription drug price fixing | first1=Brit McCandless | last1=Farmer | first2=Ayesha | last2=Siddiqi | date=12 May 2019 |publisher=CBS News}}

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",{{cite news | url=https://www.wsj.com/articles/jim-chanos-predicts-stock-drop-for-mallinckrodt-1495150731 | title=Jim Chanos Predicts Stock Drop for Mallinckrodt| work=The Wall Street Journal|date=18 May 2017| first=Gregory | last=Zuckerman | url-access=subscription}} 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".{{cite web|url=https://www.irishtimes.com/business/health-pharma/mallinckrodt-shorted-by-us-investment-group-over-acthar-drug-1.3089189|title=Mallinckrodt shorted by US investment group over Acthar drug|publisher=Irish Times|date=19 May 2017|quote=In an interview with Bloomberg TV on Thursday, Mr Chanos said he expects Congress will call for a review of Mallinckrodt pricing at some point. Asked to put a value on the company, Mr Chanos said: “We think it is zero.” Acthar is the most “egregiously” overpriced drug in the United States, he said, adding that he expects it will be replaced by generics in 10 years or that pricing will be lowered.}} 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.{{cite web|url=https://www.businessinsider.com/mallinckrodt-criticized-over-acthar-in-jama-2017-9?r=US&IR=T|title=The most respected medical journal in the US just eviscerated a drug that's cost taxpayers over $1 billion|publisher=Business Insider|date=12 September 2017}}{{cite web|url=https://www.fiercepharma.com/pharma/jama-piece-resurrects-questions-over-cost-mallinkcrodt-s-acthar|publisher=FiercePharma|date=13 September 2017|author=Eric Palmer|title=JAMA piece resurrects questions over cost of Mallinckrodt's Acthar|quote=The research from the Oregon State University’s College of Pharmacy found that the blockbuster drug’s more than $1 billion in sales have been paid for primarily by Medicare and Medicaid for conditions that often could be treated with less expensive corticosteroids. Spending by Medicare for Acthar increased 10-fold and totaled $1.3 billion from 2011 to 2015, it found. On top of that, the research letter published this week in JAMA Internal Medicine found that Acthar prescriptions often were written by a relatively small number of frequent prescribers, raising questions about how it is being marketed to those doctors by Mallinckrodt.}}

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.{{efn|Acthar is a hormone-based drug derived from pig pituitary glands that had been on the market for more than 60 years.{{cite web|url=https://www.fiercepharma.com/special-report/h-p-acthar-gel|publisher=FiercePharma|title=H.P. Acthar Gel|date=April 2014}}}} The lawsuit claimed that this situation would not be sustainable without the support of Express Scripts.{{cite web| url=https://www.fiercepharma.com/legal/dirty-data-whistleblower-retaliation-and-more-alleged-mallinckrodt-suit|publisher=FiercePharma |title=Mallinckrodt used 'dirty data' to snow payers on Acthar, whistleblower suit says|author= Eric Sagonowsky|date=13 April 2018}}

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.{{Cite web |title=Mallinckrodt - $234 Million |url=https://www.whistleblowerllc.com/success/mallinckrodt-settlement/ |access-date=2024-02-05 |website=Whistleblower Law Collaborative}} Medicaid Rules required Mallinckrodt to pay back the amount it had raised the price of Achtar above inflation.{{Cite web |last= |first= |date=2020-07-07 |title=Medicaid Drug Rebate Program Explained {{!}} Whistleblower Law |url=https://www.whistleblowerllc.com/medicaid-drug-rebate-program/ |access-date=2024-02-05 |website=Whistleblower Law Collaborative}}   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).{{Cite web |title=Mallinckrodt - $234 Million |url=https://www.whistleblowerllc.com/success/mallinckrodt-settlement/ |access-date=2024-02-05 |website=Whistleblower Law Collaborative}}

In October 2020, Mallinckrodt filed for bankruptcy, which stayed the pending False Claims Act case.{{Cite web |title=Mallinckrodt - $234 Million |url=https://www.whistleblowerllc.com/success/mallinckrodt-settlement/ |access-date=2024-02-05 |website=Whistleblower Law Collaborative}} 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.{{Cite web |title=Mallinckrodt - $234 Million |url=https://www.whistleblowerllc.com/success/mallinckrodt-settlement/ |access-date=2024-02-05 |website=Whistleblower Law Collaborative}}

=Role in opioid crisis=

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.{{Cite web|url=https://www.tampabay.com/florida-politics/buzz/2020/02/25/drugmaker-mallinckrodt-reaches-16b-opioid-settlement-with-florida-other-states/|title=Drugmaker Mallinckrodt reaches $1.6B opioid settlement with Florida, other states|website=Tampa Bay Times|language=en|access-date=2020-02-28}}

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.{{cite news | url=https://thehill.com/policy/healthcare/520622-major-opioid-maker-mallinckrodt-files-for-bankruptcy-amid-lawsuits | title=Major opioid maker Mallinckrodt files for bankruptcy amid lawsuits | work=The Hill | date=12 October 2020|access-date=12 October 2020}}

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.{{Cite web|url= https://www.stltoday.com/news/local/metro/mallinckrodt-considers-second-bankruptcy-filing-other-options/article_3a94209a-0211-11ee-9208-9b7c358cb2b2.html|title=Mallinckrodt considers second bankruptcy filing, other options|date=June 5, 2023|access-date=August 15, 2023|website=STLT Today|language=en}} However, on June 16, Mallinckrodt got an extension on their $200 million payment with a new due date of June 23, 2023.{{Cite web|url= https://www.bloomberg.com/news/articles/2023-06-16/mallinckrodt-gets-200-million-opioid-payment-deadline-extension|title=Mallinckrodt gets $200 million opioid payment deadline extension|date=June 16, 2023|access-date=August 15, 2023|website=Bloomberg|language=en}} 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.{{Cite web|url= https://www.bloomberg.com/news/articles/2023-06-16/mallinckrodt-gets-200-million-opioid-payment-deadline-extension|title=Mallinckrodt gets second $200 million opioid payment deadline extension|date=June 23, 2023|access-date=August 15, 2023|website=Bloomberg|language=en}} It later got delayed to July 7, 2023, and again to July 14, 2023.{{Cite web|url= https://www.marketscreener.com/quote/stock/MALLINCKRODT-PLC-139700961/news/Mallinckrodt-Gets-Another-Extension-for-200-Million-Opioid-Payment-44289847/|title=Mallinckrodt gets another extension for $200 million opioid payment|date=July 7, 2023|access-date=August 15, 2023|website=MarketScreener|language=en}}

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.{{Cite web|url= https://www.wsj.com/articles/mallinckrodt-sued-for-allegedly-misleading-investors-9c535a42|title=Mallinckrodt sued for allegedly misleading investors|date=July 11, 2023|access-date=August 15, 2023|website=The Wall Street Journal|language=en}} On July 14, Mallinckrodt's $200 million opioid payment was once again extended to July 21.{{Cite web|url=https://news.bloomberglaw.com/bankruptcy-law/mallinckrodt-says-opioid-trust-further-extending-payment-date|title=Mallinckrodt says opioid trust further extending payment date|date=July 14, 2023|access-date=August 15, 2023|website=Bloomberg Law|language=en}} On July 17, it was extended yet again to August 15.{{Cite web|url= https://news.bloomberglaw.com/bankruptcy-law/mallinckrodt-gets-another-extension-on-opioid-settlement-payment?context=search&index=12|title=Mallinckrodt gets another extension on opioid settlement payment|date=July 17, 2023|access-date=August 15, 2023|website=Bloomberg Law|language=en}}

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.{{Cite web|url= https://www.npr.org/2023/07/27/1190603580/drug-maker-mallinckrodt-aims-to-avoid-paying-an-opioid-settlement-to-victims|title=Mallinckrodt aims to avoid paying an opioid settlement to victims|date=July 27, 2023|access-date=August 15, 2023|website=NPR|language=en}} 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, citing 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 .{{Cite web|url= https://www.reuters.com/business/healthcare-pharmaceuticals/drugmaker-mallinckrodt-considers-second-bankruptcy-filing-other-options-2023-08-15/|title=Drugmaker Mallinckrodt moves toward second bankruptcy filing|date=August 15, 2023|access-date=August 15, 2023|website=Reuters|language=en}}

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.{{Cite web|url=https://www.reuters.com/business/healthcare-pharmaceuticals/us-drugmaker-mallinckrodt-plans-file-bankruptcy-protection-2023-08-23/|title=Mallinckrodt to file for second bankruptcy in coming days|date=August 23, 2023|access-date=August 23, 2023|website=Reuters|language=en}} 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.{{Cite web|url=https://news.bloomberglaw.com/bankruptcy-law/mallinckrodt-goes-bankrupt-with-plan-to-cut-debt-opioid-deal?context=search&index=4|title=Mallinckrodt goes bankrupt amid debt-cut plan, opioid deal|date=August 28, 2023|access-date=August 28, 2023|website=Bloomberg|language=en}} 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.{{Cite web|url=https://news.bloomberglaw.com/bankruptcy-law/nyse-mallinckrodt-in-regulatory-halt-pending-news?context=search&index=1|title=NYSE: Mallinckrodt in Regulatory Halt Pending News|date=August 28, 2023|access-date=August 28, 2023|website=Bloomberg|language=en}}

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.{{Cite web|url=https://www.reuters.com/markets/deals/drugmaker-mallinckrodt-emerges-bankruptcy-2023-11-14/|title=Drugmaker Mallinckrodt emerges from bankruptcy|date=November 14, 2023|access-date=November 18, 2023|website=Reuters|language=en}}

= Merger =

In March 2025, Mallinckrodt and Endo announced plans to merge in a deal valued at $6.7 billion.{{Cite web |date=2025-03-13 |title=Drugmakers Mallinckrodt and Endo to merge in nearly $7 billion deal |url=https://www.cnbc.com/2025/03/13/drugmakers-mallinckrodt-and-endo-to-merge.html |access-date=2025-03-14 |website=CNBC |language=en}}

Major acquisitions

  • 1981 – Mallinckrodt was listed among Fortune 500 companies{{Cite news | title = Mallinckrodt: a timeline : Business | url=https://www.stltoday.com/business/local/mallinckrodt-a-timeline/article_39f063a5-e7dc-5f2c-8bf1-2caf973c0ff0.html | work=St. Louis Post-Dispatch | date =December 16, 2011}}
  • 1982 – Avon Products, Inc. acquired Mallinckrodt
  • 1986 – International Minerals and Chemical Corporation (IMCERA Group Inc.) acquired Mallinckrodt from Avon Products
  • 1992 – Malinckrodt owned HemoCue{{cite web|url=https://www.hemocue.in/en-in/about-us/the-hemocue-story/hemocue-milestones | title=HemoCue Milestones |date=14 November 2018}}
  • 1995 – Mallinckrodt established generic pharmaceuticals business
  • 1996 – Mallinckrodt acquired maker of urology imaging systems and injectors, Liebel-Flarsheim Co.{{Cite news | title = TIMELINE: Mallinckrodt over the years - St. Louis Business Journal | url=https://www.bizjournals.com/stlouis/news/2011/12/15/mallinckrodt-over-the-years.html | work=American City Business Journals | date =December 15, 2011}}
  • 2000 – Tyco International acquired Mallinckrodt{{Cite web | title = Tyco to Buy Mallinckrodt for $3.2 Billion | work=Los Angeles Times | url = https://www.latimes.com/archives/la-xpm-2000-jun-29-fi-45946-story.html | date =June 29, 2000}}
  • 2007 – Tyco Healthcare spun off as Covidien, an independent company.{{Cite web | title = Tyco Healthcare completes spin-off as Covidien | url=http://www.bizjournals.com/stlouis/stories/2007/07/02/daily14.html?page=all | work=American City Business Journals | date =July 2, 2007}} The healthcare business units were spun off under the name Covidien.[https://www.reuters.com/article/reutersEdge/idUSN0237854220070702 Reuters press release Mon Jul 2, 2007 4:29pm EDT]
  • 2011 – Covidien announced plans to spin off Mallinckrodt Pharmaceuticals,{{Cite web | title = Covidien Spinning Off Drugs Unit to Focus on Pain Management | work=Bloomberg News | url=https://www.bloomberg.com/news/2011-12-15/covidien-plans-spin-off-of-pharmaceuticals-unit-into-stand-alone-company.html | date=December 15, 2011}}{{Cite news | first1=Jon | last1=Kamp | first2=Lauren | last2=Pollock | title=Covidien to Spin Off Drug Unit | url=https://www.wsj.com/articles/SB10001424052970203893404577100653729020644 | work=The Wall Street Journal | date=December 15, 2011}} and Mallinckrodt Plc was separated on June 28, 2013, trading on the ticker MNK from July 1, 2013.
  • 2012 – Mallinckrodt announced acquisition of CNS Therapeutics for $100 million{{Cite news | title=Covidien completes $100M CNS Therapeutics deal | url=https://www.cnbc.com/2012/10/02/covidien-completes-100m-cns-therapeutics-deal.html | agency=Associated Press | publisher=CNBC | date=11 November 2012}}
  • 2013 – Mallinckrodt spun off from Covidien and began trading under ticker symbol MNK
  • 2013 – Mallinckrodt acquired Cadence Pharmaceuticals for £1.3 billion in an Irish corporate tax inversion to escape U.S. taxes.{{Cite web | title = Mallinckrodt plc Completes $1.3 Billion Acquisition of Cadence Pharmaceuticals, Inc.| url=https://finance.yahoo.com/news/mallinckrodt-plc-completes-1-4-131200062.html | publisher = Yahoo Finance | date = 19 March 2014 | access-date = 10 January 2015}}{{cite news | url=https://www.irishtimes.com/business/health-pharma/dublin-based-pharm-firm-mallinckrodt-in-5-6bn-deal-1.1753121 | title=Deal-based pharm firm Mallinkrodt in $5.6 bn deal| newspaper=The Irish Times | date=7 April 2014}}
  • 2014 – Mallinckrodt acquired Questcor Pharmaceuticals for $5.6 billion (owner of Acthar);{{Cite web | last1 =Armstrong | first1 =Drew|last2=Serafino|first2=Phil | title=Mallinckrodt Agrees to Buy Questcor for $5.6 Billion |url= https://www.bloomberg.com/news/2014-04-07/mallinckrodt-to-buy-questcor-for-5-6-billion.html | publisher = Bloomberg | date = 7 April 2014 | access-date = 10 January 2015 }} Mallinckrodt joins the S&P 500{{Cite press release | title=Mallinckrodt Set to Join the S&P 500; Rowan to Join S&P MidCap 400; GulfMark Offshore to Join S&P SmallCap 600| url=https://www.prnewswire.com/news-releases/mallinckrodt-set-to-join-the-sp-500-rowan-to-join-sp-midcap-400-gulfmark-offshore-to-join-sp-smallcap-600-271306821.html | publisher=PR Newswire | date = 14 August 2014}}
  • 2015 – Mallinckrodt acquired Ikaria Inc. for $2.3 billion{{Cite news | url=https://www.bloomberg.com/news/articles/2015-03-05/mallinckrodt-agrees-to-acquire-ikaria-for-2-3-billion| title=Mallinckrodt Buys Ikaria for $2.3 Billion for Neonatal Care | last=McLaughlin | first=Kim | website=Bloomberg News| date=March 5, 2012}}
  • 2015 – Mallinckrodt acquired Therakos for $1.325 billion{{cite web|url=http://www.genengnews.com/gen-news-highlights/mallinckrodt-to-acquire-therakos-for-1-325b/81251605/|title=Mallinckrodt to Acquire Therakos for $1.325B - GEN News Highlights - GEN|date=10 August 2015 }} (later sold to CVC Capital Partners for $925 million in 2024.{{Cite news |url=https://www.reuters.com/markets/deals/mallinckrodt-sell-therakos-unit-cvc-capital-925-mln-2024-08-05/ |title=Mallinckrodt to sell Therakos unit to CVC Capital for $925 mln |date=August 5, 2024 |publisher=Reuters}})
  • 2015 – Mallinckrodt sold the Contrast Media and Deliver Systems portion of its portfolio to Guerbet for $270M cash with a loan financed by BNP Paribas{{Cite web|url=http://www.guerbet.com/en/our-group/news/news-2012/news/article2/guerbet-comp.html|title=Guerbet completes acquisition of Mallinckrodt's Contrast Media and Delivery Systems business (CMDS)|website=www.guerbet.com|access-date=2016-03-21|archive-date=2016-04-03|archive-url=https://web.archive.org/web/20160403133247/http://www.guerbet.com/en/our-group/news/news-2012/news/article2/guerbet-comp.html|url-status=dead}}
  • 2016 – Mallinckrodt acquired regenerative medicine company Stratatech{{cite web|url=http://www.genengnews.com/gen-news-highlights/mallinckrodt-plans-to-purchase-skin-substitute-developer-stratatech/81253081/|title=Mallinckrodt Plans to Purchase Skin Substitute Developer Stratatech - GEN News Highlights - GEN|date=11 August 2016 }}
  • 2017 – In September, Mallinckrodt acquired specialty pharmaceutical company, InfaCare Pharmaceutical Corporation.{{Cite web|url=https://www.biospace.com/article/mallinckrodt-bags-b-infacare-b-and-its-late-stage-lead-drug-in-deal-worth-425-million-/|title=Mallinckrodt Bags InfaCare And Its Late-Stage Lead Drug In Deal Worth $425 Million|website=BioSpace|access-date=Oct 12, 2020}} In November the company announced its intention to acquire Ocera Therapeutics for up to $117 million.{{cite news |url=https://www.genengnews.com/gen-news-highlights/mallinckrodt-to-acquire-ocera-therapeutics-for-up-to-117m/81255121|title=Mallinckrodt to Acquire Ocera Therapeutics for Up to $117M - GEN|website=GEN|access-date=6 June 2018}}
  • 2018 – In February 2018, Mallinckrodt acquired Sucampo Pharmaceuticals.{{cite news | url=https://www.bizjournals.com/washington/news/2018/02/13/sucampo-pharmaceuticals-closes-on-its-1-2b-sale-to.html | title=Sucampo Pharmaceuticals closes on its $1.2B sale to a U.K. company | first=Tina | last=Reed | work=American City Business Journals | date=February 13, 2018}}

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.{{Cite web|url=https://uk.reuters.com/article/us-mallinckrodt-spinoff-idUKKBN1O516U|archive-url=https://web.archive.org/web/20181206135934/https://uk.reuters.com/article/us-mallinckrodt-spinoff-idUKKBN1O516U|url-status=dead|archive-date=December 6, 2018|title=Mallinckrodt to spin off generics business, but to keep options open|first=Saumya Joseph, Tamara|last=Mathias|date=Dec 6, 2018|access-date=Oct 12, 2020|via=uk.reuters.com}} Legal liabilities that result from opioid litigation are expected to be the responsibility of Mallinckrodt Inc. or its subsidiaries following the separation.

Products

Mallinckrodt has two main product lines.{{cite web |url=https://www.sec.gov/Archives/edgar/data/1567892/000156789214000040/mnk10-k92614.htm |title=www.sec.gov }}

  • Specialty Pharmaceuticals products include branded drugs as well as specialty generics and active pharmaceutical ingredients (APIs). Products include biologics, medicinal opioids, synthetic controlled substances, and acetaminophen.
  • Medical Imaging products include contrast media and radiopharmaceuticals for medical imaging applications.

In the fourth quarter of 2014, Specialty Pharmaceuticals accounted for 74% of net sales. Key specialty pharmaceutical products include:

  • Acthar gel, an injectable biopharmaceutical used for the treatment of infantile spasms, acute exacerbations of multiple sclerosis, and certain orphan diseases. Mallinckrodt acquired this product via its acquisition of Questcor Pharmaceuticals in 2014. When Questcor acquired the drug in 2001 it sold for $40 a vial; within a year of the acquisition Questcor raised the price of the drug to $1,500 per vial and to $28,000 by 2013.{{cite news|last1=Staton|first1=Tracy|title=Questcor's Acthar maneuvers land Mallinckrodt in hot water with FTC, state AGs|url=http://www.fiercepharma.com/pharma/questcor-s-acthar-maneuvers-land-mallinckrodt-hot-water-ftc-state-ags|work=FiercePharma|date=June 18, 2015|language=en}} In 2013, Questcor acquired the US rights to a competing product, Synacthen Depot, from Novartis. In 2014 Mallinckrodt raised the price of Acthar further to $34,000.{{cite news|last1=Galeon|first1=Dom|title=Company Raises the Price of a Drug That Fights Infant Epilepsy by 85,000%|url=https://futurism.com/company-raises-the-price-of-a-drug-that-fights-infant-epilepsy-by-85000/|work=Futurism|date=21 January 2017}} The Federal Trade Commission and attorneys general from five states sued Mallinckrodt for anti-competitive behavior with regard to the acquisition of Synacthen Depot and the monopolistic pricing of Acthar, and in January 2017 the company settled, agreeing to pay $100 million and to license Synacthen Depot to a competitor.{{cite news|last1=Johnson|first1=Carolyn Y.|title=Maker of $34,000-a-vial drug to pay $100 million for allegedly preventing competition|url=https://www.washingtonpost.com/news/wonk/wp/2017/01/18/maker-of-34000-a-vial-drug-to-pay-100-million-for-allegedly-preventing-competition/|newspaper=Washington Post|date=January 18, 2017}}
  • Ofirmev is a proprietary IV formulation of acetaminophen used in conjunction with opioid painkillers in the post surgical setting.
  • Xartemis XR is a controlled release oral combination of acetaminophen and oxycodone for the treatment of acute pain.
  • Exalgo is a once-daily, long-acting form of hydromorphone, another pain drug.

Mallinckrodt specializes in producing generic controlled substances and compounds. Their products include:{{Cite web |title=Mallinckrodt Pharmaceuticals |url=https://www.mallinckrodt.com/products/generics/addiction-treatment-products/methadose-oral-concentrate-methadone-hydrochloride-oral-concentrate-usp-10-mgml-cii/ |access-date= |website=Mallinckrodt Pharmaceuticals}}

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.

See also

Notes

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References

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