Xeris Biopharma: A Catalyst for Long-Term Growth in Endocrine Therapies

Investors seeking exposure to transformative healthcare innovations should take note of Xeris Biopharma (NASDAQ: XERS), a company positioned at the intersection of strong execution, disciplined capital management, and unmet medical needs. With a robust pipeline anchored by Recorlev—a breakthrough therapy for Cushing's syndrome—and XP-8121, a once-weekly subcutaneous injection for hypothyroidism, Xeris is primed to deliver on its $1 billion revenue target for Recorlev by 2035 and peak sales of $1–$3 billion for XP-8121. Let's dissect the strategic drivers behind this compelling growth story.

Q1 2025 Results: A Foundation of Execution

Xeris's first-quarter performance underscores its ability to convert clinical and commercial momentum into tangible financial results. Total revenue surged 48% year-over-year to $60.1 million, driven by Recorlev's 141% revenue growth to $25.5 million, reflecting rapid adoption in the Cushing's syndrome market. Meanwhile, Adjusted EBITDA turned positive for the first time at $4.4 million, marking a critical inflection point toward sustained profitability.

The company's tightened 2025 revenue guidance of $260–$275 million (up from $255–$275 million) reflects confidence in its ability to scale operations while maintaining financial discipline. This is particularly notable given the $8.4 million improvement in Adjusted EBITDA compared to Q1 2024, signaling stronger operational leverage.

Recorlev: The $1B Revenue Catalyst by 2035

Cushing's syndrome, a rare but debilitating disorder caused by excessive cortisol, affects approximately 100,000–300,000 people in the U.S. and Europe. Recorlev, the first once-daily oral metyrapone therapy, is uniquely positioned to dominate this underserved market. With a 124% increase in patient numbers year-over-year, Xeris is already capturing significant market share.

The drug's $1 billion revenue target by 2035 is grounded in both its clinical efficacy and the growing awareness of Cushing's syndrome. As diagnostic rates improve and reimbursement hurdles are addressed, Recorlev's addressable market could expand exponentially. With a 4X annual growth trajectory in early adoption, Xeris is well-positioned to capitalize on this opportunity.

XP-8121: A $1–$3B Opportunity in Hypothyroidism

Hypothyroidism, affecting over 27 million Americans alone, remains a chronic condition managed primarily through daily oral levothyroxine. XP-8121, Xeris's Phase 3-ready, once-weekly subcutaneous injection, offers a transformative alternative. Phase 2 data demonstrated that patients achieved normalized thyroid levels using 45% less drug than oral therapies, with 72% preferring the subcutaneous route for its convenience.

The drug's Phase 3 readiness—supported by FDA alignment following an End-of-Phase 2 meeting—positions XP-8121 for pivotal trials in the near term. With a projected peak sales potential of $1–$3 billion, this asset could become Xeris's largest revenue driver post-2030. The upcoming June 3 Analyst Day will provide critical updates on XP-8121's clinical and commercial strategy, making it a key catalyst for investor confidence.

Financial Discipline: Navigating Debt and Growth

While Xeris's $35.1 million negative equity and $217.8 million long-term debt raise valid concerns, the company's focus on cash flow management is reassuring. With $58.4 million in cash equivalents and a positive Adjusted EBITDA, Xeris is self-funding growth without dilutive financing. Management's commitment to tightening operating margins—SG&A rose just 15% despite scaling Recorlev's commercial team—suggests a path to GAAP profitability within the next few years.

Risks and Considerations

• Competitive Landscape: Gvoke faces competition from Novo Nordisk's glucagon products, while Recorlev must prove long-term safety and efficacy.
• Regulatory Hurdles: XP-8121's Phase 3 success is critical to validating its commercial potential.
• Debt Management: Liquidity remains a near-term concern, though positive cash flow trends are mitigating risks.

Why Invest Now?

Xeris is at a pivotal juncture: its 2025 financial results are setting the stage for exponential growth, with Recorlev's revenue doubling every 12–18 months and XP-8121's Phase 3 data expected by 2026. The company's dual-engine strategy—addressing rare and mass markets—creates a multi-decade revenue runway. With shares trading at 10x 2025 sales estimates, the valuation remains compelling relative to peers.

Conclusion: A Buy for Growth-Oriented Investors

Xeris Biopharma is no longer a speculative play but a high-conviction growth story with visible catalysts. Its execution in Q1, pipeline depth, and financial discipline position it to deliver on its $1 billion Recorlev target and XP-8121's $3 billion potential. With the June 3 Analyst Day offering clarity on XP-8121's path to Phase 3, now is the time to act. For investors willing to look beyond short-term volatility, Xeris offers a rare combination of innovation, scalability, and value—making it a standout opportunity in biotech.

Action Item: Consider initiating a position in XERIS ahead of its Analyst Day, with a focus on long-term capital appreciation.

This analysis is based on publicly available information as of June 1, 2025. Past performance is not indicative of future results.