About Lannett Company

Lannett Company, Inc., through its subsidiaries, primarily develops, manufactures, markets, and distributes generic versions of brand pharmaceutical products. The company generates revenue through filing and receiving approvals for abbreviated new drug applications (ANDAs), strategic partnerships and launches of additional manufactured drugs, as well as from products acquired from Silarx Pharmaceuticals, Inc. (Silarx) and Kremers Urban Pharmaceuticals Inc. (KUPI) in 2015. The company has launched 60 products since January 2018, anchored by 24 new partner agreements, covering 36 new product launches, and complemented by 24 acquired or internally developed products. The company markets more than 100 products, mainly tablet, capsule or liquid oral generic medications. Examples of marketed products include generics, such as Posaconazole, Fluphenazine, Levothyroxine, Sumatriptan and its new drug application (NDA)-based product Numbrino. The company’s portfolio includes medications across multiple and diverse groups of therapeutic categories. The 60 products that the company launched have contributed to its revenue base, diversified its portfolio and reduced product concentration. The company’s pipeline includes 6 abbreviated new drug applications (ANDAs) pending at the Food and Drug Administration (FDA) and more than 20 additional product candidates in various stages of development. Four of the product candidates, generic Advair Diskus and generic Flovent Diskus, combination drug/devices for the treatment of asthma, and biosimilar Insulin Glargine and biosimilar Insulin Aspart for the treatment of diabetes both delivered in a device, are used medications that represent a combined U.S. addressable market opportunity. Key Products Amphetamine IR Tablets Amphetamine IR Tablets are used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. It is the generic version of Adderall. Amphetamine ER Capsules Amphetamine ER Capsules are indicated for use to treat ADHD. Studies show that the drugs improve attention and focus and reduces impulsive behaviors. Dicyclomine Tablets Dicyclomine tablets are indication for the treatment of functional bowel disorder and irritable bowel syndrome. Fluphenazine Tablets Fluphenazine tablets are used for the management of manifestations of psychotic disorders. Levothyroxine Capsules Levothyroxine capsules are soft gel capsules used to treat patients with hypothyroidism and other conditions. It is the generic version of the branded drug Tirosint. Methylphenidate CD Capsules Methylphenidate CD is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This product is the authorized generic version of the brand Metadate CD. Methylphenidate ER Methylphenidate ER is indicated for the treatment of ADHD, Attention Deficit Disorder. Numbrino Nasal Solution Numbrino Nasal Solution is used for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. Posaconazole DR Tablets Posaconazole DR tablets are used to prevent fungal infections in people who have a weak immune system resulting from certain treatments or conditions. The product is the generic version of Noxafil. Probenecid Tablets Probenecid tablets are indicated for the treatment of the hyperuricemia associated with gout and gouty arthritis. It is the generic version of the branded drug Benemid. Verapamil SR Tablets Verapamil SR tablets are a calcium channel blocker used in the treatment of high blood pressure, arrhythmia and angina. The company markets the authorized generic of Verelan PM. The company is a party to a Distribution and Supply Agreement (Agreement) with Societal CDMO Gainesville LLC (Societal) for the distribution of Verapamil SR tables. In May 2022, the company received a letter from Societal purporting to terminate the Agreement claiming that the company was in default under the Agreement. The company continues to partner on the distribution and supply of the product. The Agreement is set to expire on December 31, 2024. Strategy The key elements of the company's strategy are to focus on the large U.S. generic market and larger U.S. brand market opportunities; continually look to optimize the share and value of its existing portfolio; and focus on the strategic expansion of its product offering. Sales and Marketing and Customers The company enters into contracts with Group Purchasing Organizations (GPOs) to sell its products to their members who are its direct and indirect customers. The largest GPOs are ClarusOne, Red Oak Sourcing and Walgreens Boots Alliance Development. The company sells its pharmaceutical products to generic pharmaceutical distributors, drug wholesalers, chain drug retailers, private label distributors, mail-order pharmacies, other pharmaceutical companies, managed care organizations, hospital buying groups, governmental entities and health maintenance organizations. The pharmaceutical industry’s largest wholesale distributors, Amerisource Bergen, McKesson and Cardinal Health, each associated with one of the GPOs, accounted for 24%, 19% and 14%, respectively, of the company’s total net sales in the year ended June 30, 2022. Sales to wholesale customers include ‘indirect sales’, which represent sales to third-party entities, such as independent pharmacies, managed care organizations, hospitals, nursing homes and group purchasing organizations, collectively referred to as ‘indirect customers’. The company promotes its products through direct sales, trade shows and group purchasing organizations’ bidding processes. It also has a limited number of products that are marketed as part of its customers’ ‘private label’ programs. Private label products are manufactured by the company but distributed to the customer with a label typically containing the name and logo of the customer. Private label allows the company to leverage its internal sales efforts by using the sales and marketing efforts of those customers. Suppliers The company has entered into supply and development agreements with Summit Bioscience LLC; Sinotherapeutics, Inc.; Respirent Pharmaceuticals Co., Ltd.; HEC Pharm Group; Dexcel Pharma; Elite Pharmaceuticals; RivoPharm; and various other international and domestic companies. Research and Development The company recorded research and development expenses of $22.4 million in the year ended June 30, 2022. Regulation As the U.S.-based, publicly traded company, the company is subject to various strict U.S. compliance requirements. It follows regulations issued by the Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and various state environmental agencies in the U.S. The Federal Food, Drug and Cosmetic Act (FDCA); the Controlled Substance Act (CSA); and other federal statutes and regulations govern or influence the testing, manufacture, safety, labeling, storage, record keeping, approval, advertising, and promotion of the company’s generic drug products. The company maintains registrations and quota (limitations on the purchases of controlled substances) with the U.S. Drug Enforcement Agency (DEA) that enable it to receive, manufacture, store, develop, test and distribute controlled substances in connection with its operations. The company is subject to periodic and ongoing inspections by the DEA and similar state drug enforcement authorities to assess its ongoing compliance with the DEA’s regulations. Its quota requests require DEA approval in full for it to meet its forecasted customer demands. The company is subject to the Foreign Corrupt Practices Act (FCPA), which prohibits offering, promising, authorizing, or making payments to any foreign government official to obtain or retain business. Competition The company’s primary competitors across its product portfolio are Teva Pharmaceutical Industries Ltd.; Aurobindo Pharma Limited; and Amneal Pharmaceuticals Inc. History Lannett Company, Inc. was founded in 1942. The company was incorporated in 1942 under the laws of the Commonwealth of Pennsylvania and reincorporated in 1991 as a Delaware corporation.