Xeris Biopharma Q3 Earnings Call Highlights

Key Points

• Xeris raised its outlook after third-quarter revenue grew 44% year over year to $107.2 million, with net income of $11.3 million. It now expects 2026 revenue of $395 million to $405 million and more than $1 billion in 2030 revenue, up from its prior $750 million outlook.
• Recorlev led growth, with net revenue up 93% year over year to $71.5 million as expanded commercial efforts and increased screening boosted referrals and patient starts. Gvoke revenue declined to $21.7 million due to a one-time $4 million Medicaid adjustment, while KEVEYIS revenue rose 9% to $13 million.
• Xeris plans to start the pivotal Phase 3 study of hypothyroidism candidate XP-8121 by the end of 2026, with top-line results expected in late 2028 and a potential 2030 launch. Management estimates peak sales potential of $1 billion to $3 billion.

Xeris Biopharma NASDAQ: XERS raised its 2026 revenue guidance and its 2030 outlook after third-quarter sales increased 44% year over year, driven by rapid growth in its Cushing syndrome treatment Recorlev.

The company reported third-quarter total revenue of $107.2 million and net income of $11.3 million. It now expects 2026 revenue of $395 million to $405 million and more than $1 billion in total revenue in 2030, compared with its prior 2030 outlook of $750 million.

Chairman and CEO John Shannon said an expanded Recorlev commercial team contributed to record new referrals and patient starts during the quarter. He also said the company expects Recorlev to reach $1 billion in annual net revenue three to four years sooner than previously projected, without specifying a target year.

Recorlev Leads Sales Growth

Recorlev net revenue rose 93% from a year earlier to $71.5 million and increased 26% from the second quarter. Shannon attributed the performance to the commercial expansion that began in January, along with increased screening for hypercortisolism.

On the analyst call, Shannon said growth was coming from both existing and new prescribers and that he expects the momentum to continue into 2027 and beyond. He also pointed to updated guidance from the American Diabetes Association and the European Association for the Study of Diabetes recommending additional screening for hypercortisolism in difficult-to-control type 2 diabetes.

Asked about insurance access, Shannon said Recorlev prescriptions continue to require prior authorization and that the company must devote resources to helping clinicians and patients obtain coverage. He said he does not expect that dynamic to change immediately.

Gvoke net revenue fell to $21.7 million from $25.2 million a year earlier, despite a 5% year-over-year increase in prescriptions. Chief Financial Officer Steve Pieper said a $4 million one-time gross-to-net adjustment in the Medicaid channel offset the demand growth. Prescriptions increased 20% from the second quarter, which Shannon attributed partly to a stronger-than-expected back-to-school lift.

KEVEYIS generated $13 million in net revenue, up 9% year over year and marking its fourth consecutive quarter of growth. Shannon said the company is investing more in finding and supporting patients after receiving a U.S. patent on Oct. 13 that provides protection through at least 2043. He said newly added resources had recently completed training and would take time to ramp up.

Profit and Spending Outlook

Third-quarter adjusted EBITDA rose 77% year over year to $30.8 million, while net income increased from $0.6 million in the prior-year period. Gross margin improved to 88% from 85%, which Pieper attributed to a more favorable product mix.

Research and development expenses rose $3.6 million to $11.1 million as Xeris prepared for its XP-8121 clinical study. Selling, general and administrative expenses increased $17.6 million to $64.1 million, primarily because of higher commercial personnel costs.

For the full year, Xeris now expects R&D expenses to rise approximately $15 million from 2025, down from its prior estimate of a $25 million increase. Pieper said the change largely reflects the expected timing of XP-8121 expenses. The company increased its expected rise in SG&A expenses to approximately $60 million from $50 million, citing personnel costs and investments in near-term growth opportunities.

Pieper said all three marketed brands are expected to contribute to the higher 2030 revenue outlook, led by Recorlev. Shannon said the company’s capital priorities are its commercial products and XP-8121, followed by potential business development opportunities that fit its existing capabilities.

XP-8121 Study Planned for Year-End

Xeris remains on track to initiate Cornerstone, the pivotal Phase 3 study of its hypothyroidism candidate XP-8121, by the end of 2026. Shannon said the company expects top-line data in late 2028 and a potential approval and launch in 2030.

The company also plans pediatric and other studies as part of the program. Shannon said Xeris received a third U.S. patent covering XP-8121 on Oct. 6, with patent protection extending to October 2043. Management estimates peak sales potential of $1 billion to $3 billion for the product.

About Xeris Biopharma (NASDAQ:XERS)

Xeris Biopharma, Inc is a specialty pharmaceutical company focused on developing and commercializing therapies for patients with endocrinology, gastroenterology and other serious or chronic conditions. The company uses proprietary formulation and delivery technologies designed to make complex therapies more stable, convenient and suitable for self-administration.

Xeris' commercial portfolio includes Gvoke, a ready-to-use glucagon injection for the treatment of severe hypoglycemia in adults and children with diabetes; Recorlev (levoketoconazole), an oral therapy for endogenous hypercortisolemia associated with endogenous Cushing's syndrome; and Keveyis (dichlorphenamide), a treatment for primary periodic paralysis.

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