Xeris Biopharma Holdings, Inc. (NASDAQ: XERS)

Xeris Biopharma Holdings, Inc., often referred to as Xeris, is a biopharmaceutical company that operates in the healthcare sector. The company specializes in developing and commercializing innovative products across various therapeutic areas. Xeris is dedicated to improving patients' lives by leveraging its proprietary formulation science, XeriSol and XeriJect, to create ready-to-use, room-temperature stable, highly concentrated injectable formulations of both small and large molecules.

Xeris' main business activities revolve around the development and commercialization of pharmaceutical products. The company has a presence in the United States, where it markets three commercial products: Gvoke, Recorlev, and Keveyis. Gvoke is a ready-to-use, liquid-stable glucagon for the treatment of severe hypoglycemia, while Recorlev is a cortisol synthesis inhibitor approved for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome. Keveyis is the first therapy approved in the United States to treat hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis.

The company generates revenue through the sales of its commercial products and also by collaborating with other pharmaceutical companies on the development of formulations of their proprietary therapeutics. Xeris' primary products include Gvoke, Recorlev, Keveyis, and XP-8121, a once-weekly subcutaneous injection of levothyroxine. The company's customer base includes patients suffering from severe hypoglycemia, endogenous hypercortisolemia, and Primary Periodic Paralysis, as well as healthcare providers and pharmaceutical companies.

In terms of competition, Xeris holds a strong position in the industry due to its unique proprietary formulation science, XeriSol and XeriJect. These proprietary technologies enable the creation of ready-to-use, room-temperature stable, highly concentrated injectable formulations of both small and large molecules. This competitive advantage allows Xeris to establish a new standard of care in hypothyroidism with its product candidate, XP-8121. The company estimates that the market potential for XP-8121 is $2.0 to $3.0 billion dollars annually.

Xeris has a strong manufacturing and supply chain infrastructure, with a network of contract manufacturing organizations (CMOs) that provide high-quality and reliable manufacturing services. The company has established partnerships with several CMOs, including Bachem Americas, Inc., Pyramid Laboratories, Inc., and Regis Technologies, Inc., to ensure a stable supply of its products.

The company's proprietary formulation capabilities are protected by a portfolio of patents and patent applications covering its proprietary formulation science, XeriSol and XeriJect, as well as its product candidates. Xeris also relies on trade secrets and proprietary know-how to protect its formulation science and maintain its competitive position.

Xeris is subject to the regulations of the United States Food and Drug Administration (FDA), including the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA). The company must comply with the FDA's Good Laboratory Practice (GLP) regulations, Good Clinical Practice (GCP) regulations, and Current Good Manufacturing Practice (CGMP) regulations. Xeris must also comply with the FDA's IND and NDA regulations, including the submission of INDs and NDAs for its product candidates and the conduct of clinical trials. The company must also comply with the FDA's post-approval requirements, including the submission of annual reports and the conduct of post-marketing studies.