Xeris Biopharma Holdings, Inc. (XERS) SEC Filings & Earnings Calls

Litigation risk: patent challenge could lead to generic competition and revenue loss for KEVEYIS®.

“Defendants are generic drug manufacturers seeking to market generic dichlorphenamide products.”

Clinical and regulatory risks for XP-8121; no approved product yet.

“Forward-looking statements highlight risks of clinical trials and FDA approval.”

Gvoke revenue decline

“Gvoke Net revenue decreased by $0.9 million or 3.9% for the three months ended June 30, 2026 compared to the three months ended June 30, 2025.” · word for word

Dependence on Recorlev for growth

“Recorlev revenue growth of 80.6% drives overall performance; Gvoke and Keveyis are flat or declining.”

Net loss increased significantly due to non-cash charge from convertible notes exchange.

“Net loss $31.1M vs $1.9M prior year; includes $31M non-cash charge.”

Gvoke revenue declined 4% YoY, indicating potential market share loss or demand softness.

“Gvoke net revenue $22.5M vs $23.5M prior year.”

SG&A expenses increased 37% YoY, outpacing revenue growth, raising efficiency concerns.

“SG&A increased $16.6M or 37% in Q2 2026.”

Significant dilution to existing shareholders from conversion of convertible notes into common stock.

“8.6 million shares issued in exchange for $33.5M of debt”

Share dilution from note exchange may pressure stock price.

“Issuance of shares to noteholders in exchange for $23M principal.”

Accumulated deficit

“Our accumulated deficit was $669.1 million.” · word for word

Dependence on continued financing

“We may continue to seek public equity and debt financing to meet our capital requirements. There can be no assurance that such funding may be available to us on acceptable terms, or at all” · word for word

Gvoke revenue flat; potential competition or market saturation risk.

“Gvoke net revenue was $20.8 million – flat compared to the first quarter of 2025” · word for word

SG&A expenses increased 21% YoY, partly due to commercial expansion; profitability dependent on continued revenue growth.

“Selling, general and administrative (SG&A) expenses increased $9.1 million or 21%” · word for word

Keveyis net pricing pressure

“Keveyis® net revenue was $47.6 million - a decrease of approximately 4% compared to the year ended December 31, 2024. The decrease was due to unfavorable net pricing” · word for word

XP-8121 clinical and regulatory risk

“Delivered a renewed vision of XP-8121 at our first Investor Day that pegged peak sales from $1.0 billion to $3.0 billion and committed to the initiation of a first patient dosed in Phase 3 in the second half of 2026” · word for word

Recorlev Generic Competition Risk

“We received Paragraph IV certification notice letters (each, a “Notice Letter”) from three pharmaceutical companies (each, an “ANDA Filer”), providing notification to us that each ANDA Filer had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of RECORLEV®.” · word for word

Keveyis Generic Erosion

“Keveyis Net revenue decreased by $1.9 million or 3.8% for the year ended December 31, 2025 compared to the year ended December 31, 2024. The decrease was due to unfavorable net pricing ($5.0 million or 10.1%)” · word for word

Single-Source Supplier Concentration

“We rely on a number of single-source suppliers, such as Bachem API, Pyramid for drug product, and SHL for auto-injector and final product assembly” · word for word

Customer Concentration

“For the years ended December 31, 2025, 2024 and 2023, four customers accounted for 97% of the Company’s gross product revenue, respectively.” · word for word

Drug Pricing Policy Risk

“The IRA includes several provisions that will impact our business to varying degrees, including provisions that reduce the out-of-pocket cap for Medicare Part D beneficiaries to $2,000 starting in 2025; impose new manufacturer financial liability on certain drugs in Medicare Part D, allow the United States government to negotiate Medicare Part B and Part D p” · word for word

R&D and SG&A expenses expected to increase significantly in 2026 (+$25M and +$45M respectively), which could pressure margins if revenue growth slows.

“2026 Outlook: 'R&D expense to increase by approximately $25 million... SG&A expense to increase by approximately $45 million'”

Keveyis revenue declined 4% in FY2025 due to unfavorable net pricing; continued pricing pressure could impact future revenue.

“Full Year 2025 Highlights: 'Keveyis $47,649 thousand -3.8%... due to unfavorable net pricing, partially offset by higher patient demand'”

Potential generic competition if lawsuit unsuccessful.

“ANDA filers seeking approval for generic Recorlev; Paragraph IV certification.”

XP-8121 still investigational; regulatory and commercial risks remain.

“XP-8121 is an investigational, ready-to-use liquid formulation” · word for word

Accumulated deficit

“Our accumulated deficit was $682.4 million.” · word for word

Keveyis revenue decline

“Keveyis net revenue decreased $0.3 million or 2.1% for the three months ended September 30, 2025.”

Dependence on Recorlev for growth; Keveyis revenue decline; R&D and SG&A expense increases.

“Keveyis revenue down 2% YoY; R&D expenses up 27% in Q3; SG&A up 3% in Q3.”