8-K: Xeris Biopharma Posts Record Q3 2025 Results, Raises Guidance

Xeris Biopharma Holdings, Inc. announced record third-quarter 2025 financial results, with total product revenue up 40% year-over-year, and updated its full-year 2025 revenue guidance.

Summary

• Delivered a record-breaking quarter, driven by increased patient demand across all three products.
• Total product revenue increased 40% year-over-year to $74 million for the three months ended September 30, 2025.
• Recorlev revenue grew 109% year-over-year to $37 million for the three months ended September 30, 2025.
• Updated full-year 2025 total revenue guidance to $285-$290 million, previously $280-$290 million, implying 42% growth at the midpoint compared to last year.
• Net income for the third quarter was $0.6 million, compared to a net loss of $15.7 million in the same period last year.
• Adjusted EBITDA for the third quarter was $17.4 million, an improvement of $20.1 million compared to the third quarter of 2024.
• Year-to-date total revenue was $206.0 million, a 44.1% increase from $143.0 million in the prior year.
• Year-to-date net loss improved by 79% to $10.5 million, or ($0.07) per share, compared to $49.7 million, or ($0.34) per share, in the prior year period.
• Year-to-date Adjusted EBITDA was $34.3 million, an improvement of $41.4 million compared to the nine months ended September 30, 2024.

Sentiment

Score: 8

Explanation: The company reported record financial results, significantly increased revenue, achieved net income, and raised its full-year guidance, indicating strong operational execution and market demand for its key products, particularly Recorlev. While there are increased R&D and SG&A expenses and a slight decline in Keveyis revenue, the overall financial performance and outlook are very positive.

Positives

• Achieved record-breaking quarterly financial results.
• Total product revenue increased 40% year-over-year to $74 million in Q3 2025.
• Recorlev revenue surged 109% year-over-year to $37 million in Q3 2025, validating its significant growth potential.
• Full-year 2025 total revenue guidance was raised to $285-$290 million, up from $280-$290 million, implying 42% growth at the midpoint.
• Reported net income of $0.6 million in Q3 2025, a significant turnaround from a net loss of $15.7 million in Q3 2024.
• Adjusted EBITDA improved by $20.1 million to $17.4 million in Q3 2025.
• Year-to-date net loss improved by 79% to $10.5 million.
• Year-to-date Adjusted EBITDA improved by $41.4 million to $34.3 million.
• Gvoke net revenue increased 10% in Q3 2025 due to higher volume and favorable net pricing.
• Cost of goods sold decreased by $2.6 million (19%) in Q3 2025, primarily due to a reduction of Gvoke inventory write-offs.

Negatives

• Keveyis net revenue decreased 2% to $11.9 million in Q3 2025 and 9% year-to-date, primarily due to unfavorable net pricing.
• Research and development (R&D) expenses increased $1.6 million (27%) in Q3 2025 and $3.8 million (20%) year-to-date, reflecting personnel-related expenses for XP-8121 and technology platforms.
• Selling, general and administrative (SG&A) expenses increased $1.5 million (3%) in Q3 2025 and $11.5 million (9%) year-to-date, mainly due to incremental personnel-related expenses, particularly for the Recorlev commercial organization.
• Royalty, contract and other revenue decreased 77.5% to $0.317 million in Q3 2025.

Risks

• Financial position and need for financing, including to fund product development programs or commercialization efforts.
• Ability of products to achieve and maintain market acceptance in a competitive business environment.
• Reliance on third-party suppliers, including single-source suppliers.
• Reliance on third parties to conduct clinical trials.
• Ability of product candidates to compete successfully with existing and new drugs.
• Ability to protect intellectual property and proprietary technology.
• Accuracy and completeness of assumptions and ability to accurately estimate future financial results and market opportunities.
• General macroeconomic and geopolitical conditions, including the possibility of an economic downturn, changes in governmental priorities and resources, announced or implemented tariffs or export controls, and market volatility.

Future Outlook

The company updated its full-year 2025 total revenue guidance to $285-$290 million, implying 42% growth at the midpoint compared to last year. Management's focus remains on executing and investing in opportunities to propel sustained growth into 2026 and beyond, driven by continued momentum across the business and ongoing development of its pipeline, including XP-8121.

Management Comments

• "We delivered another record-breaking quarter, driven by increased patient demand across all three products."
• "Total product revenue grew 40% year-over-year, highlighting the strength of our portfolio and the meaningful difference we're making in the lives of patients and providers alike."
• "Recorlev led the way, with revenue growing 109% to $37 million, further validating its significant growth potential."
• "Our year-to-date performance underscores the strength of our growth engine and the effectiveness of our strategic execution."
• "With momentum continuing to build across the business, we are updating our 2025 total revenue guidance to $285-$290 million, which implies 42% growth at the midpoint compared to last year."
• "As we progress through the final quarter, our focus remains on executing and investing in opportunities that will propel sustained growth into 2026 and beyond."

Industry Context

Xeris Biopharma operates in the fast-growing biopharmaceutical sector, focusing on innovative products for conditions like endogenous Cushing's syndrome (Recorlev), severe hypoglycemia (Gvoke), and primary periodic paralysis (Keveyis). The strong growth in Recorlev and Gvoke suggests successful market penetration and demand for their specialized therapies, aligning with a broader industry trend towards targeted treatments for rare or specific conditions. The company is also investing in pipeline development (XP-8121 for hypothyroidism) and technology platforms (XeriSol, XeriJect), indicating a strategy to expand its therapeutic footprint and leverage proprietary drug delivery systems, which is a common approach for biopharma companies seeking competitive advantages and long-term value creation.

Comparison to Industry Standards

• The 40% year-over-year total product revenue growth and 109% Recorlev revenue growth are exceptionally strong for a biopharmaceutical company, often exceeding average industry growth rates for established products. Many large-cap pharmaceutical companies typically see single-digit to low double-digit growth for mature products, while high growth rates like Xeris's are more common in emerging biotech firms with newly launched, breakthrough therapies or significant market expansion.
• Achieving net income of $0.6 million in Q3 2025, a significant swing from a substantial loss in the prior year, demonstrates strong operational leverage and commercial execution. This is a key milestone for many growing biopharma companies transitioning from a development-heavy phase to sustained profitability, often outperforming peers still in significant loss-making stages.
• The updated full-year revenue guidance of $285-$290 million, implying 42% growth at the midpoint, positions Xeris among the higher-growth companies in the biopharma space, especially considering its existing commercial portfolio. This growth rate is competitive with or superior to many specialized pharmaceutical companies.
• The investment in R&D for XP-8121 (Phase 3-ready) and technology platforms is consistent with industry standards for biopharma companies aiming to sustain long-term growth through pipeline expansion and innovation, demonstrating a balanced approach between commercial success and future development.

Stakeholder Impact

• Shareholders: Positive impact due to strong financial performance, increased revenue, profitability, and raised guidance, potentially leading to increased share value.
• Employees: Increased R&D and SG&A expenses reflect personnel-related investments, suggesting continued employment and growth opportunities, particularly in the Recorlev commercial organization and R&D.
• Customers (Patients/Providers): Increased patient demand across all three products indicates successful product adoption and positive impact on patient lives.
• Creditors: Improved financial health and profitability could enhance the company's creditworthiness.

Next Steps

• Senior management will participate in 1x1 meetings at the Jefferies Global Healthcare Conference on November 17-19, 2025, in London, UK.
• Senior management will participate in 1x1 meetings and a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, in New York City, NY.
• Focus on executing and investing in opportunities to propel sustained growth into 2026 and beyond.
• Ongoing development of XP-8121 (Phase 3-ready) and other early-stage programs leveraging technology platforms.

Key Dates

Recommendation

The company delivered exceptional Q3 2025 results, marked by significant revenue growth (40% YoY total product revenue, 109% Recorlev revenue), a return to net income, and a substantial improvement in Adjusted EBITDA. The upward revision of full-year revenue guidance to $285-$290 million signals strong confidence in continued momentum. While there are increased operating expenses and a slight decline in Keveyis, the overall trajectory, driven by robust demand for key products and strategic investments in the pipeline, positions Xeris Biopharma for sustained growth and improved profitability. This performance indicates strong operational execution and market acceptance, making it an attractive investment.

Keywords

Xeris Biopharma, XERS, Q3 2025 Earnings, Biopharmaceutical, Recorlev, Gvoke, Keveyis, Cushing's syndrome, Hypoglycemia, Periodic Paralysis, Revenue Guidance, Adjusted EBITDA, Financial Results