What Xeris Biopharma Holdings, Inc. told the SEC could break it.

Xeris sells its commercial products (Recorlev, Gvoke, Keveyis) primarily to a handful of drug wholesalers and a specialty pharmacy that resell to retail pharmacies and patients. Four customers accounted for over 90% of gross product revenue in each of 2025, 2024 and 2023, and the same four were ~90–97% of net trade accounts receivable. It expects to keep depending on a small number of customers for a high percentage of revenue, so the loss of, or a change in terms or buying behavior by, any of these large distributors — or a customer's financial distress affecting receivables — could materially harm revenue and cash flow, and may not be replaceable. The customers are unnamed (standard big-wholesaler concentration), so an aggregate concentration risk rather than an edge. Severity high.

“four customers accounted for over 90% of the Company's gross product revenue.”

Xeris relies on a number of single-source suppliers and manufacturers for the supply of all of its products and product candidates, and such disruptions have occurred in the past and could recur. Each product has a single point of failure: Recorlev depends on Regis (sole-source levoketoconazole API, Illinois) and Lonza (sole-source drug product, Florida); Gvoke depends on Bachem (glucagon API, Switzerland), Pyramid (drug product) and SHL (auto-injector device and final assembly); and Taro produces all Keveyis requirements. Because pharmaceutical suppliers are qualified into FDA-approved manufacturing processes, re-sourcing any single-source CMO is slow and costly, so a financial, quality, capacity or geopolitical disruption at any one would interrupt commercial supply of the affected product. The named suppliers are captured as edges; this records the systemic single-source vulnerability. Severity high.

“The Company relies on a number of single source suppliers and manufacturers for the supply of its products and product candidates.”

Xeris has a global supply chain and manufactures some components of its products outside the United States, including in Taiwan and Israel. This concentrates parts of its supply in geopolitically sensitive jurisdictions: the war between Israel and Hamas has in the past and could in the future directly and indirectly affect its operations (e.g., damage, destruction or disruption to supplier facilities), and Taiwan carries China–Taiwan tension and natural-disaster exposure. A disruption to these offshore component sources would compound its single-source CMO risk and could interrupt manufacturing and distribution of finished products. Suppliers in these locations are component-level, so a geographic concentration risk. Severity medium.

“We have a global supply chain and manufacture some components of our products outside the United States, including without limitation, in Taiwan and Israel.”

Xeris is exposed to a fast-moving pharmaceutical trade and pricing-policy environment, which is especially acute given that key inputs (e.g., Bachem glucagon API in Switzerland) and components (Taiwan, Israel) are imported. In September 2025 the administration announced a 100% tariff on brand-name or patented drugs unless pharmaceutical companies expand U.S. manufacturing (currently on hold) — a measure that, if enacted, could materially affect Xeris's supply chain and costs — on top of early-2025 import tariffs on Canada, Mexico, the EU and China. Separately, U.S. drug-pricing policy (IRA Medicaid rebates and Part D redesign, and the December 2025 CMS-proposed GLOBE international-benchmark rebate model for Medicare Part B) pressures net pricing. A specific, current trade-and-pricing policy exposure. Severity medium.

“in September 2025, the current administration also announced a 100% tariff on brand-name or patented drugs unless pharmaceutical companies expand their manufacturing operations in the U.S.”