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XERS • CIK 0001867096
Xeris Biopharma Holdings, Inc. along with its subsidiaries, is referenced herein as the "Company", "Xeris", "Xeris Biopharma", "we" or "our". Throughout this document, unless otherwise noted, references to Gvoke include Gvoke PFS, Gvoke HypoPen, and Gvoke Kit. Overview We are a commercial-stage biopharmaceutical company focused on developing and commercializing therapies for people with chronic endocrine and neurological diseases in the United States. We offer Recorlev for the treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome, Gvoke for the treatment of severe hypoglycemia, and Keveyis for the treatment of Primary Periodic Paralysis ("PPP"). We are advancing our Phase 3-ready pipeline product, XP-8121, once-weekly subcutaneous ("SC") levothyroxine, which leverages our proprietary technology XeriSol. Commercial Products Our top priority is maximizing the potential of our three commercial products: • Recorlev is a cortisol synthesis inhibitor approved for the treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative. Endogenous Cushing’s syndrome is a rare but serious and potentially fatal endocrine disease caused by chronic elevated cortisol exposure. Recently published data has shown that hypercortisolemia may be a contributor to several widespread and chronic medical conditions suggesting that the prevalence of the condition may be significantly higher than previously believed. We believe this therapy represents a significant commercial opportunity in the United States, with the potential to generate approximately $1 billion in annual net revenue at peak penetration. • Gvoke is a ready-to-use, liquid-stable glucagon for the treatment of severe hypoglycemia. The product is indicated for use in pediatric and adult patients with diabetes age two years and above and can be administered in two simple steps. We estimate that more than 14 million people in the United States are at heightened risk of severe hypoglycemia and, per guidelines issued by the American Diabetes Association and others, should have a ready-to-use glucagon product like the Gvoke HypoPen with them at all times. The estimated total addressable market for this drug is approximately $5.0 billion in the United States. • Keveyis is the first therapy approved in the United States to treat hyperkalemic, hypokalemic, and related variants of PPP. PPP is a rare genetic, neuromuscular disorder that can cause extreme muscle weakness and/or paralysis; some forms are also commonly associated with myotonia or muscle stiffness. The estimated total addressable market for this therapy is greater than $0.5 billion in the United States. Our Pipeline We prioritize our development efforts on programs that leverage our commercial capabilities or our proprietary formulation technologies, principally our lead pipeline program, XP-8121. Our company name, Xeris, is derived from the ancient Greek word xērós meaning 'dry' or 'without water/non-aqueous'. Our proprietary, non-aqueous formulations are designed to enable the convenient injection of medicines previously uninjectable or poorly injectable when utilizing aqueous approaches. XeriSol and XeriJect offer the opportunity to create ready-to-use, room-temperature stable, highly concentrated, injectable formulations of both small and large molecules. • XP-8121: We are in the process of developing the first and only, once-weekly, subcutaneous injection of levothyroxine for the treatment of hypothyroidism. We plan to initiate a Phase 3 clinical trial of XP-8121 in 2026. The estimated total addressable market for this therapy is 3-5 million patients or more in the United States which we estimate is a $1.0 to $3.0 billion peak net sales opportunity. • Partnerships: We are pursuing formulation and development partnerships to apply our XeriSol and XeriJect formulation technologies to enhance the drug delivery and clinical profile of other companies’ proprietary drugs and biologics. Currently, Xeris is working on a number of formulation feasibility programs in the areas of small molecules, peptides, biologics and monoclonal antibodies. 6 Table of Contents Our Strategy Our strategy is to build a profitable biopharmaceutical company focused on developing and commercializing therapies for people with chronic endocrine and neurological diseases.…