About Assertio Holdings

Assertio Holdings, Inc. operates as a specialty pharmaceutical company. The company offers differentiated products to patients utilizing a non-personal promotional model. The company’s commercial portfolio of branded products focuses on three areas, such as neurology, rheumatology, and pain and inflammation. The company has built its commercial portfolio through a combination of increased opportunities with existing products, as well as through the acquisition or licensing of additional approved products. The company’s primary marketed products are: INDOCIN (Indomethacin) Suppositories: A suppository and oral solution of indomethacin used both in hospitals and out-patient settings. Both products are nonsteroidal anti-inflammatory drug (NSAID), indicated for moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to severe ankylosing spondylitis; moderate to severe osteoarthritis; acute painful shoulder (bursitis and/or tendinitis); and acute gouty arthritis. The company also offers INDOCIN (indomethacin) Oral Suspension. Otrexup (Methotrexate) Injection for Subcutaneous Use: A once weekly single-dose auto-injector containing a prescription medicine, methotrexate. Otrexup is folate analog metabolic inhibitor indicated for the management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy; and symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy. Sympazan (Clobazam) Oral Film: A benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients aged two years of age or older. Sympazan is the only product to offer clobazam in a convenient film with PharmFilm technology. Sympazan is taken without water or liquid, adheres to the tongue, and dissolves to deliver clobazam. SPRIX (Ketorolac Tromethamine) Nasal Spray: A prescription NSAID indicated in adult patients for the short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at an opioid level. SPRIX is a non-narcotic nasal spray that provides patients with moderate to moderately severe short-term pain a form of ketorolac that is absorbed rapidly but does not require an injection administered by a healthcare provider. CAMBIA (Diclofenac Potassium for Oral Solution): A prescription NSAID indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older. CAMBIA can help patients with migraine pain, nausea, photophobia (sensitivity to light), and phonophobia (sensitivity to sound). CAMBIA is not a pill; it is a powder, and combining CAMBIA with water activates the medicine in a unique way. Zipsor (Diclofenac Potassium) Liquid Filled Capsules: A prescription NSAID used for relief of mild-to-moderate pain in adults (18 years of age and older). Zipsor uses proprietary ProSorb delivery technology to deliver a finely dispersed, rapid and consistently absorbed formulation of diclofenac. Other commercially available products include OXAYDO (oxycodone HCI, USP) tablets for oral use only —CII. On October 27, 2022, the company completed a transaction to acquire an exclusive license for Sympazan (clobazam) oral film and Sympazan product inventory (the Sympazan Acquisition) from Aquestive Therapeutics, Inc. (Aquestive). Under the terms of the definitive agreement governing the Sympazan Acquisition, the company acquired an exclusive license for the Sympazan intellectual property from Aquestive. The patent allowance was granted in the fourth quarter of 2022, which extends the patent coverage until 2040. The company also entered into a long-term supply agreement with Aquestive for Sympazan. Collaboration and License Agreements Miravo Pharmaceuticals: The Company has a license agreement with Tribute Pharmaceuticals Canada Ltd. (known as Miravo Pharmaceuticals, or Miravo) granting them the rights to commercially market CAMBIA in Canada. Miravo independently contracts with manufacturers to produce a specific CAMBIA formulation in Canada. The company receives royalties on net sales on a quarterly basis, as well as certain one-time contingent milestone payments upon the occurrence of certain events. Business Strategy The key elements enable the company to be commercially successful in leadership with a proven track record of successful results; significant experience in completing business development transactions in the healthcare space, such as mergers, asset acquisitions, asset divestitures, and commercialization/licensing arrangements; a strategy that leverages digital and non-personal promotion to engage its customers and drive efficiency; experience in key elements of commercialization, including but not limited to, market access, patient services, distribution, brand and digital marketing, non-personal promotion, analytics, and market research; impactful brand promise for physicians and patients that reduces hassle and improves accessibility through access programs; and commercial capabilities and financial position that enable it to seamlessly expand its product offerings. The company’s strategy is to grow through product acquisitions, commercialization agreements, licensing or technology agreements, equity investments, and business combinations. The company’s products have been acquired or licensed through business development activities. The company continues to seek additional products, with a preference for accretive, on-market products that have patent life or exclusivity remaining that it can add to its portfolio of medicines. Secondarily, the company also remains open to late-stage assets or other investments into medical devices, informatics, or technology. The company is seeking products that are a fit with its commercial platform and can be leveraged and distributed via digital and non-personal promotional means. The company’s platform is specialty area agnostic and it can potentially acquire products across a number of therapeutic areas, while requiring minimal additional resources. Promotion of Products Beginning in 2021, the company transformed its commercial model. The promotion of the company’s products is executed by a non-personal promotion model, utilizing omnichannel marketing and a digital selling approach. The company has also integrated its virtual sales team with a view to maximize effectiveness with the providers and various sites-of-care that utilize its therapies. Using virtual and digital promotion allows the company to quickly scale resources to meet the needs of its growing portfolio and is intended to ensure that it can be competitive across multiple therapeutic areas. The company’s commercial organization consists of multiple capabilities, including marketing, trade and distribution, and market access. The organization’s focus is finding new and novel ways to distribute product and improve patient access to the company’s therapies. Seasonality The company’s product revenues have historically been lower in the first quarter of the year as compared to the fourth quarter of the preceding year. This variation is influenced by both wholesaler buying patterns and the reset of annual limits on deductibles and out-of-pocket costs of many health insurance plans and government programs at the beginning of each calendar year (year ended December 31, 2022). Customers Three large, national wholesale distributors represent the vast majority of the company’s revenues from net product sales. For the year ended December 31, 2022, the company’s customers included AmerisourceBergen Corporation; McKesson Corporation; and Cardinal Health. Manufacturing The company has manufacturing, packaging and supply agreements with sole commercial suppliers for each of its marketed products, as follows: INDOCIN Products - Patheon Pharmaceuticals, Inc. (Patheon) and Cosette Pharmaceuticals, Inc.; Otrexup - Antares Pharma, Inc. and Pharmascience Inc.; Sympazan - Aquestive Therapeutics, Inc.; SPRIX - Jubilant HollisterStier LLC and Sharp Packaging Solutions; CAMBIA - MiPharm, S.p.A. and Tioapack; Zipsor - Catalent Ontario Limited (Catalent) and Mikart Inc.; and OXAYDO - UPM Pharmaceuticals, Inc. Intellectual Property Trademarks Assertio, Zyla, INDOCIN, Otrexup, Sympazan, SPRIX, CAMBIA, Zipsor and OXAYDO are trademarks owned by or licensed to Assertio. Patents and Proprietary Rights As of December 31, 2022, the U.S. patents the company owned or had in-licensed, and their expiration dates and the marketed products they cover, are as follows: Otrexup: U.S. Patent Nos. (Exp. Dates) include 8,021,335 (October 4, 2026); 8,480,631 (March 19, 2030); 8,562,564 (January 24, 2026); 8,579,865 (March 19, 2030); 8,814,834 (May 27, 2031); 8,945,063 (March 19, 2030); 9,421,333 (March 19, 2030); 9,533,102 (January 24, 2026); 9,629,959 (January 24, 2026); 9,867,949 (March 10, 2029); 10,709,844 (March 10, 2029); 11,446,441 (January 24, 2026); and 11,497,753 (March 19, 2030). Sympazan: U.S. Patent Nos. (Exp. Dates) include 8,603,514 (April 3, 2024); 8,765,167 (February 20, 2024); and 11,541,002 (January 31, 2040). SPRIX: U.S. Patent Nos. (Exp. Dates) include 8,277,781 (March 13, 2029) ; and 8,551,454 (March 13, 2029). CAMBIA: U.S. Patent Nos. (Exp. Dates) include 7,759,394 (June 16, 2026); 8,097,651 (June 16, 2026); 8,927,604 (June 16, 2026); and 9,827,197 (June 16, 2026). Zipsor: U.S. Patent Nos. (Exp. Dates) include 7,662,858 (February 24, 2029); 7,884,095 (February 24, 2029); 7,939,518 (February 24, 2029); 8,110,606 (February 24, 2029); 8,623,920 (February 24, 2029); and 9,561,200 (February 24, 2029). OXAYDO: U.S. Patent Nos. (Exp. Dates) include 7,510,726 (November 26, 2023); 7,981,439 (November 26, 2023); 8,409,616 (November 26, 2023); 8,637,540 (November 26, 2023); 9,492,443 (May 26, 2024); and 7,201,920 (March 16, 2025). Government Regulation The company, its suppliers, contract manufacturers and other entities involved in the manufacturing and distribution of approved drugs are required to comply with certain post-approval requirements and are subject to periodic unannounced inspections by the Food and Drug Administration and state agencies to assess compliance with Current Good Manufacturing Practices requirements. Federal statutes that apply to the company include the federal Anti-Kickback Statute, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration in exchange for or to generate business, including the purchase or prescription of a drug, that is reimbursable by a federal healthcare program, such as Medicare and Medicaid, and the Federal False Claims Act, which prohibits knowingly and willingly presenting, or causing to be presented, for payment to the federal government any false, fraudulent or medically unnecessary claims for reimbursed drugs or services. History The company was founded in 1995. It was incorporated in the state of California in 1995. The company was formerly known as Depomed, Inc. and changed its name to Assertio Therapeutics, Inc. in 2018. Further, the company changed its name to Assertio Holdings, Inc. in 2020.