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Company Description

Mallinckrodt plc (MNK) is described in recent company communications as a global specialty pharmaceutical business focused on therapeutics that address unmet patient needs, alongside a significant presence in generics, sterile injectables, and active pharmaceutical ingredients. The company operates in the pharmaceutical preparation manufacturing industry within the broader manufacturing sector.

According to Mallinckrodt, its operations are organized into two primary businesses. The Brands business concentrates on autoimmune and rare diseases across multiple therapeutic areas, including endocrinology, gastroenterology, hepatology, neonatal respiratory critical care, nephrology, neurology, pulmonology, ophthalmology, orthopedics, rheumatology, and urology. Within this portfolio, the company highlights products such as Acthar Gel (repository corticotropin injection), which is used in several autoimmune and inflammatory conditions, and TERLIVAZ (terlipressin) for injection, indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

The Par Health business, as described in Mallinckrodt’s disclosures, encompasses generic drugs, sterile injectables, and active pharmaceutical ingredients. This business includes a product portfolio that features controlled substances, patches, solid oral extended-release and immediate-release products, liquids, semi-solids, powders and ophthalmics, as well as APIs. Par Health is presented as a distinct generics and sterile injectables platform within the Mallinckrodt group.

In corporate updates, Mallinckrodt has reported that it completed a merger with Endo, Inc., combining Mallinckrodt’s existing operations with Endo’s branded pharmaceuticals, generic pharmaceuticals, sterile injectables, and related assets. Following this merger, the combined company operated through three reportable segments: Specialty Brands, Generics, and Sterile Injectables. The Specialty Brands segment combined Mallinckrodt’s historical specialty brands with Endo’s branded pharmaceuticals, focusing on autoimmune and rare diseases and including Acthar Gel, XIAFLEX and other branded therapeutics. The Generics segment combined Mallinckrodt’s specialty generics with Endo’s generic pharmaceuticals, while the Sterile Injectables segment reflected Endo’s historical sterile injectables business.

Subsequently, Mallinckrodt announced the completion of a spin-off of its combined generics and sterile injectables businesses under the name Par Health, Inc. In the same communication, Mallinckrodt stated that, going forward, it would be known as Keenova Therapeutics and would focus on developing, manufacturing and commercializing branded therapeutics for patients with rare or unaddressed conditions. Keenova is described as comprising the Specialty Brands segment, while Par Health comprises the Generics and Sterile Injectables segments.

In the “About Mallinckrodt” sections of its press releases, the company characterizes itself as dedicated to enhancing lives by providing therapeutics that strive to address unmet patient needs, and as a manufacturer of generics, sterile injectables and active pharmaceutical ingredients. In the “About Keenova” sections of later releases, the combined branded therapeutics business is described as a global developer and manufacturer of branded therapeutics with a diversified brands portfolio across therapeutic areas of significant unmet need, including endocrinology, gastroenterology, hepatology, immunology, neonatal respiratory critical care, nephrology, neurology, pulmonology, ophthalmology, orthopedics, rheumatology and urology.

According to these communications, Keenova is globally headquartered in Dublin, Ireland, and benefits from a U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania and Wisconsin. Mallinckrodt and Keenova also state that they use their websites as channels for distributing important company information, including press releases, investor presentations and other financial information.

Business segments and therapeutic focus

Brands business / Specialty Brands:

  • Focuses on autoimmune and rare diseases.
  • Covers therapeutic areas such as endocrinology, gastroenterology, hepatology, neonatal respiratory critical care, nephrology, neurology, pulmonology, ophthalmology, orthopedics, rheumatology and urology, as described in company materials.
  • Includes branded therapeutics such as Acthar Gel and XIAFLEX, which are cited in Mallinckrodt’s and Keenova’s press releases.

Par Health business:

  • Includes generic drugs, sterile injectables and active pharmaceutical ingredients.
  • Features controlled substances and a range of dosage forms, including patches, solid oral extended-release and immediate-release products, liquids, semi-solids, powders and ophthalmics, as outlined in the company’s segment descriptions.

Corporate developments referenced in company communications

Company news releases state that Mallinckrodt and Endo completed a merger to create a combined therapeutics business with branded, generics and sterile injectables operations. They further state that Mallinckrodt completed a spin-off of the Par Health generics and sterile injectables businesses and that the remaining branded therapeutics business is being introduced as Keenova Therapeutics. Keenova is described as intending to pursue a listing of its ordinary shares on the New York Stock Exchange in a future period, subject to board approval and other conditions, and as focusing on a diversified portfolio of branded therapies across multiple specialty therapeutic areas.

Industry classification

Based on the provided classification, Mallinckrodt is in the pharmaceutical preparation manufacturing industry within the manufacturing sector. Its activities, as described in its own disclosures, include the development, manufacture, marketing and distribution of specialty pharmaceutical products, branded therapeutics, generic pharmaceuticals, sterile injectables and active pharmaceutical ingredients.

Frequently asked questions (FAQ)

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Frequently Asked Questions

What industry is Mallinckrodt plc (MNK) in?

Mallinckrodt is in the pharmaceutical preparation manufacturing industry within the broader manufacturing sector. Company materials describe it as a global specialty pharmaceutical business involved in therapeutics, generics, sterile injectables and active pharmaceutical ingredients.

How does Mallinckrodt describe its main business segments?

Mallinckrodt describes two main businesses: a Brands business focused on autoimmune and rare diseases across multiple therapeutic areas, and the Par Health business, which includes generic drugs, sterile injectables and active pharmaceutical ingredients. Following its merger with Endo and the spin-off of Par Health, the branded therapeutics business is referred to as Keenova Therapeutics.

What therapeutic areas does Mallinckrodt’s Brands business focus on?

According to the company’s disclosures, the Brands business focuses on autoimmune and rare diseases in therapeutic areas including endocrinology, gastroenterology, hepatology, neonatal respiratory critical care, nephrology, neurology, pulmonology, ophthalmology, orthopedics, rheumatology and urology.

What is Par Health in relation to Mallinckrodt?

Par Health is described by Mallinckrodt as the combined generics and sterile injectables business, including generic drugs, sterile injectables and active pharmaceutical ingredients. After the merger with Endo, Par Health comprises the Generics and Sterile Injectables segments that were separated from the branded therapeutics business.

How does the company describe Keenova Therapeutics?

In its press releases, Mallinckrodt states that, moving ahead, it will be known as Keenova Therapeutics, focusing on developing, manufacturing and commercializing branded therapeutics for patients with rare or unaddressed conditions. Keenova is described as a global developer and manufacturer of branded therapeutics with a diversified brands portfolio across multiple therapeutic areas of significant unmet need.

Where is the branded therapeutics business headquartered?

Company communications state that Keenova, the branded therapeutics business introduced following the spin-off of Par Health, is globally headquartered in Dublin, Ireland and has a U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania and Wisconsin.

What types of products are mentioned in Mallinckrodt’s Brands business?

In its own disclosures, the company cites branded therapeutics such as Acthar Gel (repository corticotropin injection) and XIAFLEX (collagenase clostridium histolyticum) within the Specialty Brands segment, along with other branded therapies for autoimmune and rare diseases.

What kinds of products are included in the Par Health business?

Mallinckrodt describes the Par Health business as including generic drugs, sterile injectables and active pharmaceutical ingredients. The generics portfolio includes certain controlled substances, patches, solid oral extended-release and immediate-release products, liquids, semi-solids, powders and ophthalmics, as outlined in the company’s segment descriptions.

How does Mallinckrodt communicate with investors and the public?

Mallinckrodt and Keenova state in their press releases that they use their websites as channels for distributing important company information, including press releases, investor presentations and other financial information, and to expedite public access to time-critical information in advance of or in lieu of separate SEC filings or press releases.

What is the relationship between Mallinckrodt, Endo and Keenova?

Company news releases explain that Mallinckrodt and Endo completed a merger, creating a combined therapeutics business with branded, generics and sterile injectables operations. The combined generics and sterile injectables businesses were then spun off as Par Health, and the remaining branded therapeutics business is being introduced under the name Keenova Therapeutics.