Xeris Biopharma — Third Quarter 2026 Earnings Summary
Financial Performance:
- Total revenue increased 44% year-over-year to $107.2 million for the three months ended September 30, 2026, compared to $74.4 million in the prior year period.
- Net product revenue grew 43% year-over-year to $106.3 million, driven by a 93% increase in Recorlev net revenue to $71.5 million.
- Gvoke revenue decreased 14% year-over-year to $21.7 million, impacted by a one-time $4 million gross-to-net adjustment.
- Keveyis revenue increased 9% year-over-year to $13.0 million.
- Gross margin improved to 88% in Q3 2026 from 85% in the prior year period, driven by favorable product mix.
- Net income for the quarter was $11.3 million, compared to $0.6 million in the prior year period.
- Adjusted EBITDA for the quarter was $30.8 million, an improvement of $13.3 million year-over-year.
- For the nine months ended September 30, 2026, total revenue was $282.5 million, up 37% year-over-year.
- Gross margin for the nine-month period was 87%, up from 84% in the prior year period.
- Net loss for the nine months ended September 30, 2026, was $17.6 million, compared to a net loss of $10.5 million in the prior year period; the loss included a one-time non-cash charge of approximately $30.8 million related to the 2028 Convertible Notes exchange.
- Adjusted EBITDA for the nine months ended September 30, 2026, was $65.1 million, an improvement of $30.8 million year-over-year.
- Cash and cash equivalents were $131.1 million as of September 30, 2026.
- Long-term debt, net of unamortized debt issuance costs, was $189.7 million as of September 30, 2026.
Guidance and Future Outlook:
- Raised full-year 2026 total revenue guidance to a range of $395 million to $405 million.
- Raised 2030 total revenue outlook to more than $1 billion, up from approximately $750 million.
- Expects Recorlev to reach nearly $1 billion in annual net revenue three to four years sooner than previously expected.
- Anticipates initiating the pivotal Phase 3 Cornerstone study for XP-8121 by the end of 2026.
- Projects topline data for the XP-8121 Cornerstone study in late 2028, with potential approval and launch in 2030.
Business Segments and Product Lines:
- Recorlev commercial team transitioned from build to yield, delivering record referrals and new patient starts.
- XP-8121, an investigational once-weekly subcutaneous levothyroxine for hypothyroidism, is advancing with the Cornerstone study designed to enroll 500 adults and adolescents at more than 50 U.S. sites.
- The XP-8121 program includes Capstone (pediatric study), Touchstone (patients with inconsistent thyroid control), and a real-world evidence program.
- Gvoke experienced stronger-than-historical back-to-school prescription demand in the third quarter.
- Research and development expenses increased 48% year-over-year to $11.1 million in Q3 2026, primarily to support XP-8121.
- Selling, general and administrative expenses increased 38% year-over-year to $64.1 million in Q3 2026, reflecting higher personnel-related expenses to support the commercial enterprise.
Market and Competitive Landscape:
- Xeris is positioned as a leader in endocrine and rare diseases with three commercially available products: Recorlev, Gvoke, and Keveyis.
- Scientific presentations highlighted unmet clinical needs, including the opportunity to increase adoption of ready-to-use glucagon products and the potential for cortisol normalization to improve cardiometabolic parameters.
- The company is leveraging real-world evidence to evaluate patient populations treated with oral levothyroxine.
Risks and Challenges:
- The nine-month net loss included a significant one-time non-cash charge related to the 2028 Convertible Notes exchange.
- Gvoke revenue was negatively impacted by a one-time gross-to-net adjustment.
- Future results depend on the successful execution of clinical trials, regulatory approvals, and market acceptance of new products like XP-8121.
- The company faces risks related to reliance on third-party suppliers, clinical trial execution, and protection of intellectual property.
Management Commentary and Tone:
- CEO John Shannon stated the company is on a "new growth curve" that is accelerating the near-term outlook and is on a path to reach more than $1 billion in total revenue in 2030.
- Management noted that the new trajectory reflects growth from the full enterprise, with Recorlev leading the growth.
- Shannon expressed confidence in the momentum across Recorlev, Gvoke, and Keveyis, citing the decision to raise guidance as a result of this strength.
Other Key Points:
- Fully retired all 8.00% Convertible Senior Notes due 2028 on July 15, 2026, eliminating approximately $34 million of debt and $3 million in annual interest expense.
- Received U.S. Patent No. 12,751,937 for XP-8121 on October 6, 2026, expected to expire in 2043.
- Received U.S. Patent No. 12,758,502 covering Keveyis on October 13, 2026, providing intellectual property protection through at least 2043.
- Menassie M. Taddese was appointed to the Board of Directors as an independent director effective November 2, 2026.
- Total shares outstanding were 182,700,038 as of October 30, 2026.
- Upcoming events include presentations at the American Thyroid Association 95th Annual Meeting, Jefferies London Healthcare Conference, and Piper Sandler Healthcare Conference.
- Company
- XERIS BIOPHARMA HOLDINGS INC
- Sector
- Healthcare
- Industry
- Biotechnology