Organon & Co 10-K (2022-03-21)

For the fiscal year ended December 31, 2021

 

 

Business

 

Overview

 

Organon & Co. ("Organon") is a global health care company formed through a spinoff from Merck & Co., Inc. ("Merck") to focus on improving the health of women throughout their lives. Organon's focus is on women's health as its primary therapy area, and is the only large global pharmaceutical company currently in existence to do so.

 

spin-off : an unexpected but useful result of an activity that is designed to produce something else / a book, a film, a television programme, or an object that is based on a book, film or television series that has been very successful

 

primary : connected with the education of children between the ages of about five and eleven / main; most important; basic

 

pharmaceutical : connected with making and selling medical drugs

 

 

 

Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Organon is a global health care company that develops and delivers innovative health solutions through a portfolio of prescription therapies within women's health, biosimilars and established brands (the "Organon Products").

 

therapeutic : helping to treat an illness / helping you to relax

 

prescription : an official piece of paper on which a doctor writes the type of medicine you should have, and which enables you to get it from a chemist's / medicine that your doctor has ordered for you

 

biosimilars : a drug that is very similar to one that was originally produced by a different company

 

 

 

Organon sells these products through various channels including drug wholesalers and retailers, hospitals, government agencies and managed health care providers such as health maintenance organizations, pharmacy benefit managers and other institutions. Organon operates six manufacturing facilities, which are located in Belgium, Brazil, Indonesia, Mexico, the Netherlands and the United Kingdom ("UK").

 

 

 

Organon's operations include the following product portfolios, which constitute one operating segment engaged in developing innovative health solutions

 

constitute : to be considered to be something / to form a group legally or officially / to be the parts that together form something 

 

 

 

Women's Health: Organon has a portfolio of contraception and fertility brands, including Nexplanon® (etonogestrel implant) (sold as Implanon NXT™ in some countries outside the United States), a long-acting reversible contraceptive, which is a class of contraceptives that is recognized as the most effective type of hormonal contraception available to patients with a lower long-term average cost.

 

contraception : the practice of using artificial methods to avoid becoming pregnant when having sex; the methods of doing this

 

reversible : (of clothes, materials, etc.) that can be turned inside out and worn or used with either side showing / (of a process, an action or a disease) that can be changed so that something returns to its original state or situation

 

 

 

Organon's mission is to be the world's leading women's health company and to deliver a better and healthier every day for every woman. Organon plans to continue building on its strengths in reproductive health and fertility as it assembles a suite of health options that help address the areas of high unmet needs for women from adolescence to menopause and beyond.

 

reproductive : connected with reproducing babies, young animals or plants 

 

unmet : (of needs, etc.) not satisfied

 

menopause : the time during which a woman gradually stops menstruating, usually at around the age of 50

 

 

 

Biosimilars: Organon's current portfolio spans across immunology and oncology treatments. Organon plans to continue evaluating opportunities in other potential therapeutic areas, including ophthalmology, diabetes and neuroscience.

 

span : to last all through a period of time or to cover the whole of it / to include a large area or a lot of things

 

 

 

Organon's oncology biosimilars have been launched in 20 countries and Organon's immunology biosimilars have been launched in five countries. All five biosimilars in Organon's portfolio have launched in certain countries globally, including two biosimilars in the United States.

 

oncology : the scientific study of and treatment of tumours in the body

 

 

 

Organon expects to grow its existing portfolio through future launches in other therapeutic areas, both through Organon's partnership with its development partner, Samsung Bioepis, as well as through other potential partners. Organon's existing biosimilars portfolio positions Organon for success in this attractive and fast growing area of health care with several major biologics that will lose patent protection in the next decade.

 

 

 

Established Brands: Organon has a portfolio of established brands, which generally are beyond market exclusivity, including leading brands in cardiovascular, respiratory, dermatology and non-opioid pain management.

 

exclusivity : the fact of being of a high quality and expensive and therefore not often bought or used by most people / the practice in a group or society of not allowing other people from different groups to become members or be included

 

 

 

A number of Organon's established brands lost exclusivity years ago and have faced generic competition for some time, yet still contribute meaningful profitability. Organon intends to stimulate the performance of its established brands products through renewed focus and attention on strategic marketing to create a significant source of capital to fuel its growth aspirations.

 

stimulate : to make something develop or become more active; to encourage something / to make somebody interested and excited about something

 

 

 

Organon believes its established brands products will, over time, continue to deliver meaningful revenue and operating profit that can be redirected into organic and inorganic growth opportunities in key product areas and geographies.

 

redirect : to use something, for example money, in a different way or for a different purpose / to send something to a different address or in a different direction

 

 

 

Organon's established brands portfolio is supported by its large commercial and manufacturing capabilities, including a global network that enables Organon to distribute products to patients in more than 140 countries and territories.

 

 

 

Led by the women's health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon's products produce strong cash flows that will support investments in innovation and future growth opportunities in women's health.

 

 

 

In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

 

commercialize : to use something to try to make a profit, especially in a way that other people do not approve of

 

 

 

Since becoming a standalone company, Organon has expanded its women's health portfolio through four acquisitions:

 

 

Acquired Alydia Health, a commercial stage company focused on the treatment of postpartum hemorrhage.

 

postpartum : after giving birth

 

hemorrhage : a large flow of blood from a damaged blood vessel (= tube that carries blood around the body)

 

 

Entered into a licensing agreement with ObsEva for the global development, manufacturing and commercial rights to ebopiprant (OBE022), an investigational agent being evaluated as a potential treatment for preterm labor.

 

 

Acquired Forendo, a clinical-stage drug development company whose lead candidate, FOR-6219, is an investigational agent being evaluated as a potential treatment for endometriosis, and whose pipeline also includes a pre-clinical program targeting polycystic ovarian syndrome (PCOS).

 

 

Entered into an agreement to acquire the rights to Marvelon™ (ethinylestradiol, desogestrel)¹ and Mercilon™ (ethinylestradiol, desogestrel)¹ (two combined hormonal oral contraceptives) in several Asian markets, adding to the 20 markets where Organon already maintained rights to these products.

 

 

 

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