ANI Pharmaceuticals Stock

ANI Pharmaceuticals, Inc. and its consolidated subsidiaries (ANI) is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals, including for diseases with high unmet medical need.

The company is focused on delivering growth by scaling up the Rare Disease business through the successful launch of its lead asset, Cortrophin Gel, strengthening the company’s generics business with enhanced development capability, innovation in established brands and leveraging the company’s North American manufacturing capabilities. The company’s three pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota, and one is located in East Windsor, New Jersey, are together capable of producing oral solid dose products, as well as semi-solids, liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment. The company has ceased operations at its subsidiary in Oakville, Ontario, Canada as of March 31, 2023. This action was part of ongoing initiatives to capture operational synergies following the company’s acquisition of Novitium Pharma LLC (‘Novitium’) in November 2021.

The company had a commercial portfolio of 116 products with a wide variety of indications and a robust portfolio of pipeline products as of December 31, 2023. This portfolio is the result of internal research and development, acquisitions of businesses, acquisitions of Abbreviated New Drug Applications (‘ANDAs’), New Drug Applications (‘NDAs’), product rights, and entry into agreements to obtain the distribution rights for various products..

Strategy

The company’s growth strategy is driven by the following key growth drivers: building a successful rare disease platform; strengthening the company’s generics, established brands, and other segment through continued investment in the company’s generic research and development capability and increased focus on niche opportunities; and generic product development considerations.

Competitive Generic Therapy

The FDA Reauthorization Act of 2017 (‘FDARA’) created a new pathway by which FDA may, at the request of the applicant, designate a drug with ‘inadequate generic competition’ as a competitive generic therapy (‘CGT’). At the request of the applicant, the FDA may also expedite the review of an ANDA for a drug designated as a CGT. Under the CGT pathway, the FDA provides a statutory provision for a 180-day exclusivity period for certain first to market applicants whose ANDA received a CGT designation. The company’s Novitium subsidiary has developed a strong track record of obtaining CGT approvals and the company expect to continue to develop generic drugs under the CGT pathway.

Products

A complete list of the company’s generic and branded pharmaceutical products and descriptions is posted on its website, www.anipharmaceuticals.com.

Government Regulation

The company’s facilities, procedures, operations, and testing of products are subject to periodic inspection by the FDA, the DEA, and other authorities. In addition, the FDA conducts pre-approval and post-approval reviews and plant inspections to determine whether the company’s systems and processes are in compliance with cGMP and other FDA regulations.

The DEA regulates certain drug products containing controlled substances, pursuant to the U.S. Controlled Substances Act (‘CSA’). Certain of the company’s products contain significant components that are classified as controlled substances. CSA and DEA regulations impose specific requirements on manufacturers and other entities that handle these substances including registration, recordkeeping, reporting, storage, security, and distribution.

Medicaid and Medicare, both of which are the U.S. federal health care programs administered by CMS, are major payors of pharmaceutical products, including those the company produces.

Patents, Trademarks, and Licenses

The company owns the trademark names for most of its branded products, including Apexicon, Cortenema, Purified Cortrophin Gel, Cortrophin-Zinc, Inderal LA, Inderal XL, InnoPran XL, Lithobid, Reglan, Vancocin, and Veregen. The company licenses the trademark names for Atacand, Atacand HCT, Arimidex, Casodex, Oxistat, and Pandel. With the exception of a license for patent technology for Inderal XL, InnoPran XL, and Veregen, the company does not license any patents associated with these products. Further, patent protection and market exclusivity for these branded products have expired, with the exception of the Veregen product, which has three patents. One patent expired in 2022 and the remaining two patents expire in 2025 and 2026.

Distribution Agreements

In addition to selling products under the company’s own NDAs and ANDAs, the company enters into marketing and distribution agreements with third parties in which the company sells products under ANDAs or NDAs owned or licensed by these third parties. These products are sold under the company’s own label.

Customers

The company’s customers purchase and distribute the company’s products. The company’s customers include major national wholesalers. The company’s products are sold by major retail pharmacy chains, distributors, national mail order houses, as well as group purchasing organizations.

Sales, Marketing, and Distribution

The company markets, sells, and distributes its products in the United States. The company’s products are distributed through the following channels:

Wholesalers. The company conducts business with the three major wholesalers in the United States: Cencora, Inc., Cardinal Health, and McKesson.

Retail Market Chains. The company conducts business with all the major retail chains in the United States which includes CVS, Rite Aid, Kroger, Walmart, and Walgreens.

Distributors and Mail Order Pharmacies. The company has contracts with several major distributors and mail order pharmacies in the United States, including Anda, Smith Drug Company, Morris Dickson, CVS Caremark, Centerwell, and ExpressScripts.

Group Purchasing Organizations. The company has contracts with group purchasing organizations in the United States, such as ClarusONE, Walgreens Boots Alliance Development Group, Red Oak Sourcing, Econdisc, Optisource, Rx Sourcing Strategies, The Premier Group, Topco, The Buyer’s Consortium, Managed Health Care Associates Inc., Asembia, Premier Inc, and Kaiser Permanente.

Specialty Pharmacies. In the company’s Rare Disease segment the company contracts with specialty pharmacies.

Hospitals. In the company’s Rare Disease segment the company contracts with certain hospital systems.

Competition

Principal competitors for the pharmaceutical market in which the company does business include, but are not limited to, Amneal Pharmaceuticals, Inc., Apotex Inc., Aurobindo Pharma, Camber Pharmaceuticals Inc., Hikma Pharmaceuticals plc, Lupin Pharmaceuticals, Inc., Mallinckrodt Pharmaceuticals, Rising Pharmaceuticals, Inc., Strides Pharma Inc., Sun Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA, Inc., Viatris Inc., and Zydus Pharmaceuticals USA.

Research and Development

The company’s research and development costs totaled $34.3 million for the year ended December 31, 2023.

Trademarks

Apexicon, Cortenema, Purified Cortrophin Gel, Inderal LA, Inderal XL, InnoPran XL, Lithobid, Reglan, Vancocin, and Veregen are registered trademarks subject to trademark protection and are owned by ANI Pharmaceuticals, Inc. and its consolidated subsidiaries. Cortrophin-Zinc is a trademark owned by ANI and its consolidated subsidiaries pending registration. Atacand and Atacand HCT are the property of AstraZeneca AB and are licensed to ANI for the U.S. sales of those products. Arimidex and Casodex are the property of AstraZeneca UK Limited and are licensed to ANI for the U.S. sales of those products. Oxistat is the property of Fougera Pharmaceuticals Inc. and licensed to ANI for the U.S. sales of Oxistat Lotion. Pandel is property of Taisho Pharmaceutical Co, Ltd. and licensed to ANI for the U.S. sales of Pandel creme.

History

ANI Pharmaceuticals, Inc., a Delaware corporation, was founded in 2001. The company was incorporated in 2001.