Mallinckrodt

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Mallinckrodt Pharmaceuticals plc
public liability company
Traded as
ISINIE00BBGT3753
IndustryPharmaceutical
PredecessorMallinckrodt Inc. (before the 2013 tax inversion to Ireland)
Founded1867
Headquarters
Key people
Mark Trudeau (CEO), Matthew Harbaugh (CFO)
RevenueUS$3.221.6 billion (2017)[1]
US$1.771.2 billion (2017)[1]
Number of employees
3,600 (March 2018)
Websitemallinckrodt.com

Mallinckrodt Pharmaceuticals is an Irish–tax registered manufacturer of specialty pharmaceuticals (namely, adrenocorticotropic hormone), generic drugs and imaging agents.[2] In 2017 it generated 90% of sales from the U.S. healthcare system. While Mallinckrodt is headquartered in Ireland for tax purposes, its operational headquarters is in the U.S.[3] Mallinckrodt's 2013 tax inversion to Ireland drew controversy when it was shown their main drug Acthar, was Medicaid's most expensive drug.[4]

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.[5] 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.[5]

The company has been implicated as a major contributor to the prescription opioid scandal around the over-prescription of oxycodone in the United States.[6]

History[edit]

Foundation[edit]

In 1867, the Mallinckrodt brothers, Gustav, Otto and Edward, founded G. Mallinckrodt & Co. in St. Louis, Missouri.[7] The Mallinckrodt family had immigrated from Germany, and Otto and Edward both returned to Germany, the leader in chemistry at the time, for advanced training.[8] Mallinckrodt Chemical Works was incorporated 15 years later. 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.[7] 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.[9]

Ties to Washington University in St. Louis[edit]

Throughout its history, Washington University 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 Medical School Radiology Department resulting in the creation of the Mallinckrodt Institute of Radiology.[10] 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.[11] Mallinckrodt is currently partnering with 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.[12]

Tax inversion to Ireland (2013)[edit]

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.[13] 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 a number of U.S. tax inversions that the Wall Street Journal reported to be using their lower tax-platform to acquire further U.S. pharmaceutical firms, such as the $5.6 billion acquisition of Questor in 2014.[14] 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".[15]

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.[16] 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.[17]

Mallinckrodt net sales by region (SEC 10-K filing, 2017)[5]
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

Acthar controversy[edit]

Price of Mallinckrodt's H.P Acthar drug dating back to Questor's acquisition of Acthar from Sanofi Aventis in July 2001 for $100,000.[4]

In December 2012, the New York Times in an article on Mallinckrodt's main drug H.P. Acthar Gel,[a] reported that "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".[19] 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 anti-trust 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".[20] The city of Rockford, Illinois is now suing Mallinckrodt and pharmacy benefit management company Express Scripts for their failure to reduce Acthar's price. [21]

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",[22] 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".[18] 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.[4][23]

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.[b][17] The lawsuit claimed that this situation would not be sustainable without the support of Express Scripts.[17][25]

Prescription opioid scandal[edit]

A US Drug Enforcement Administration (DEA) database was made public in 2019 that tracks every opioid pill sold in the United States from 2006 through 2012. The database shows that 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.[6]

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.[6]

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.”[6]

Major acquisitions[edit]

  • 1981 – Mallinckrodt was listed among Fortune 500 companies[26]
  • 1982 – Avon Products, Inc. acquired Mallinckrodt
  • 1986 – International Minerals and Chemical Corporation (IMCERA Group Inc.) acquired Mallinckrodt from Avon
  • 1988 – Malinckrodt was mentioned in The New York Times as the only company to receive an exception from the DEA for cocaine possession and processing[27]
  • 1992 – Malinckrodt owned HemoCue[28]
  • 1995 – Mallinckrodt established generic pharmaceuticals business
  • 1996 – Mallinckrodt acquired maker of urology imaging systems and injectors, Liebel-Flarsheim Co.[29]
  • 2000 – Tyco International acquired Mallinckrodt[30]
  • 2007 – Tyco Healthcare spun off as Covidien, an independent company.[31] The healthcare business units were spun off under the name Covidien.[32]
  • 2011 – Covidien announced plans to spin off Mallinckrodt Pharmaceuticals,[33][34] and Mallinckrodt Plc was separated on June 28, 2013, trading on the ticker MNK from July 1, 2013.[2]
  • 2012 – Mallinckrodt announced acquisition of CNS Therapeutics for $100 million[35]
  • 2013 – Mallinckrodt spun off from Covidien and began trading under ticker symbol MNK[2]
  • 2013 – Mallinckrodt acquired Cadence Pharmaceuticals for £1.3 billion in an Irish corporate tax inversion to escape U.S. taxes.[36][37]
  • 2014 – Mallinckrodt acquired Questcor Pharmaceuticals for $5.6 billion (owner of Acthar);[38] Mallinckrodt joins the S&P 500[39]
  • 2015 – Mallinckrodt acquired Ikaria Inc. for $2.3 billion[40]
  • 2015 – Mallinckrodt acquired Therakos for $1.325 billion[41]
  • 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 [42]
  • 2016 – Mallinckrodt acquired regenerative medicine company Stratatech[43]
  • 2017 – In September, Mallinckrodt acquired specialty pharmaceutical company, InfaCare Pharmaceutical Corporation.[44] In November the company announced its intention to acquire Ocera Therapeutics for up to $117 million.[45] In late December the company announced it would acquire Sucampo Pharmaceuticals Inc for around $840 million, gaining control of constipation drug - Amitiza and a number of experimental rare disease treatments.[46]

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.[47] Legal liabilities that result from opioid litigation are expected to be the responsibility of Mallinckrodt Inc. or its subsidiaries following the separation.[6]

Products[edit]

Mallinckrodt has two main product lines.[48]

  • 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 acetominophen.
  • 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[48]

  • 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.[49] 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.[50] In 2013, Questcor acquired the US rights to a competing product, Synacthen Depot, from Novartis.[50] In 2014 Mallinckrodt raised the price of Acthar further to $34,000.[51] 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.[49]
  • Ofirmev is a proprietary IV formulation of acetominophen used in conjunction with opioid painkillers in the post surgical setting.
  • Xartemis XR is a controlled release oral combination of acetominophen and oxycodone for the treatment of acute pain.
  • Exalgo is a once-daily, long-acting form of hydromorphone, another pain drug.

Key generic specialty products include:[48]

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 of the brain or liver.

As of 1988, Mallinckrodt was the only company in the US that is allowed to receive cocaine, which it has used to make cocaine hydrochloride, a prescription drug used in hospitals as a local anesthetic by eye and ear, nose and throat doctors.[27]

See also[edit]

Notes[edit]

  1. ^ 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.[18]
  2. ^ Acthar is a hormone-based drug derived from pig pituitary glands that had been on the market for more than 60 years.[24]

References[edit]

  1. ^ a b "News & Media - Mallinckrodt Pharmaceuticals".
  2. ^ a b c "Mallinckrodt". Wall Street Journal. 1 July 2013. Retrieved 18 July 2013.
  3. ^ "Mallinckrodt agrees deal to exploit Irish tax base". Irish Independent. 8 April 2014. 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.
  4. ^ a b c "The most respected medical journal in the US just eviscerated a drug that's cost taxpayers over $1 billion". Business Insider. 12 September 2017.
  5. ^ a b c "SEC Form 10-K: Mallinckrodt public limited company". Securities and Exchange Commission. p. 51. Results of Operations: Net Sales
  6. ^ a b c d e Aaron C. Davis, Shawn Boburg and Robert O'Harrow Jr. Little-known makers of generic drugs played central role in opioid crisis, records show. The Washington Post, July 27.
  7. ^ a b "SHSMO-St. Louis s0452 Mallinckrodt, Edward Jr. (1878–1967)" (PDF). State Historical Society of Missouri. Retrieved 5 February 2015.
  8. ^ Mercelis, Joris. "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.
  9. ^ Evens, Ronald G. (2009-01-07). "Roentgenologic Examination of the Gallbladder (Cholecystography)". JAMA. 301 (1): 100–101. doi:10.1001/jama.2008.893. ISSN 0098-7484.
  10. ^ "S0452 Mallinckrodt, Edward Jr. (1878–1967) Papers, 1798–1981" (PDF). State Historical Society of Missouri: Manuscripts. State Historical Society of Missouri. p. 2. Retrieved 23 April 2017.
  11. ^ "Mallinckrodt Center". Washington University in St. Louis. Retrieved 2019-08-19.
  12. ^ "Mallinckrodt boosts rare-disease research at Washington University". Washington University School of Medicine in St. Louis. 2018-08-06. Retrieved 2019-08-19.
  13. ^ "Deal-based pharm firm Mallinckrodt in $5.6 bn deal". Irish Times. 7 April 2014.
  14. ^ Liz Hoffman (7 July 2015). "The Tax Inversion Wave Keeps Rolling". Wall Street Journal. 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.
  15. ^ "Mallinckrodt won't give up Irish home". Irish Times. 8 December 2015. 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.
  16. ^ Jonathan D. Rockoff; Nina Trentmann (11 February 2018). "New Tax Law Haunts Companies That Did 'Inversion' Deals". Wall Street Journal. 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.
  17. ^ a b c Linette Lopez (11 April 2018). "'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". Business Insider. 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.
  18. ^ a b "Mallinckrodt shorted by US investment group over Acthar drug". Irish Times. 19 May 2017. 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.
  19. ^ Andrew Pollock (29 December 2012). "Questcor Finds Profits, at $28,000 a Vial". New York Times.
  20. ^ Jessica Dye. "Mallinckrodt shares fall after it announces $100m antitrust settlement". Financial Times. 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.
  21. ^ Brit McCandless Farmer & Ayesha Siddiqi. "60 Minutes reports: prescription drug price fixing". CBS News.
  22. ^ Gregory Zuckerman (18 May 2017). "Jim Chanos Predicts Stock Drop for Mallinckrodt". Wall Street Journal.
  23. ^ Eric Palmer (13 September 2017). "JAMA piece resurrects questions over cost of Mallinckrodt's Acthar". FiercePharma. 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.
  24. ^ "H.P. Acthar Gel". FiercePharma. April 2014.
  25. ^ Eric Sagonowsky (13 April 2018). "Mallinckrodt used 'dirty data' to snow payers on Acthar, whistleblower suit says". FiercePharma.
  26. ^ "Mallinckrodt: a timeline : Business". Retrieved 6 November 2012.
  27. ^ a b May, Clifford D. (1988-07-01). "How Coca-Cola Obtains Its Coca". The New York Times. ISSN 0362-4331. Retrieved 2016-04-18.
  28. ^ "HemoCue Milestones". 14 November 2018.
  29. ^ "TIMELINE: Mallinckrodt over the years - St. Louis Business Journal". Retrieved 6 November 2012.
  30. ^ "Tyco to Buy Mallinckrodt for $3.2 Billion - Los Angeles Times". Retrieved 18 March 2013.
  31. ^ "Tyco Healthcare completes spin-off as Covidien - St. Louis Business Journal". Retrieved 6 November 2012.
  32. ^ https://www.reuters.com/article/reutersEdge/idUSN0237854220070702%7C Reuters press release Mon Jul 2, 2007 4:29pm EDT
  33. ^ "Covidien Spinning Off Drugs Unit to Focus on Pain Management - Bloomberg". Retrieved 6 November 2012.
  34. ^ "Covidien to Spin Off Drug Unit". Wall Street Journal. Retrieved 6 November 2012.
  35. ^ "Covidien completes $100M CNS Therapeutics deal - Businessweek". Retrieved 6 November 2012.
  36. ^ "Mallinckrodt plc Completes $1.3 Billion Acquisition of Cadence Pharmaceuticals, Inc". Yahoo Finance. 19 March 2014. Retrieved 10 January 2015.
  37. ^ "Deal-based pharm firm Mallinkrodt in $5.6 bn deal". Irish Times. 7 April 2014.
  38. ^ Armstrong, Drew; Serafino, Phil (7 April 2014). "Mallinckrodt Agrees to Buy Questcor for $5.6 Billion". Bloomberg. Retrieved 10 January 2015.
  39. ^ "Mallinckrodt Set to Join the S&P 500; Rowan to Join S&P MidCap 400; GulfMark Offshore to Join S&P SmallCap 600". Yahoo Finance. 14 August 2014. Retrieved 10 January 2015.
  40. ^ McLaughlin, Kim. "Mallinckrodt Buys Ikaria for $2.3 Billion for Neonatal Care". Bloomberg.com. Retrieved 2016-08-12.
  41. ^ "Mallinckrodt to Acquire Therakos for $1.325B - GEN News Highlights - GEN".
  42. ^ "Guerbet completes acquisition of Mallinckrodt's Contrast Media and Delivery Systems business (CMDS)". www.guerbet.com. Retrieved 2016-03-21.
  43. ^ "Mallinckrodt Plans to Purchase Skin Substitute Developer Stratatech - GEN News Highlights - GEN".
  44. ^ https://www.biospace.com/article/releases/mallinckrodt-bags-b-infacare-b-and-its-late-stage-lead-drug-in-deal-worth-425-million-/?s=79
  45. ^ "Mallinckrodt to Acquire Ocera Therapeutics for Up to $117M - GEN". GEN. Retrieved 6 June 2018.
  46. ^ Mathias, Tamara. "Mallinckrodt to buy Sucampo for about $840 million". Retrieved 6 June 2018.
  47. ^ https://uk.reuters.com/article/us-mallinckrodt-spinoff/mallinckrodt-to-spin-off-generics-business-but-to-keep-options-open-idUKKBN1O516U
  48. ^ a b c "www.sec.gov".
  49. ^ a b Johnson, Carolyn Y. (January 18, 2017). "Maker of $34,000-a-vial drug to pay $100 million for allegedly preventing competition". Washington Post.
  50. ^ a b Staton, Tracy (June 18, 2015). "Questcor's Acthar maneuvers land Mallinckrodt in hot water with FTC, state AGs". FiercePharma.
  51. ^ Galeon, Dom (21 January 2017). "Company Raises the Price of a Drug That Fights Infant Epilepsy by 85,000%". Futurism.

External links[edit]