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Achieved a defining milestone of financial self-sustainability, effectively removing the need for external funding to support the current strategy and pipeline.
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Recorlev served as the primary growth engine, nearly doubling its patient base to approximately 700 patients by year-end 2025.
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Gvoke provided durable and predictable revenue growth of 14% for the full year, supported by broad market access and alignment with treatment guidelines.
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Keveyis outperformed expectations by increasing the average number of patients on therapy through comprehensive patient support services.
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Operating leverage improved significantly, enabling the company to report its first full year of net income and nearly $60 million in adjusted EBITDA.
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Management attributes the 44% full-year revenue growth to disciplined execution and broad-based demand across all three commercial products.
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The company doubled its Recorlev commercial footprint in January 2026 to scale patient support and sales interactions for long-term growth.
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2026 revenue guidance of $375 million to $390 million assumes over 30% growth driven primarily by continued Recorlev expansion.
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Phase III initiation for XP-8121 is planned for the second half of 2026, requiring a $25 million step-up in R&D investment.
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Management expects to remain adjusted EBITDA positive in 2026 despite significant increases in R&D and a $45 million increase in SG&A spending.
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The XP-8121 Phase III timeline is gated by the need to scale up commercial manufacturing and finalize the go-to-market device to avoid future regulatory delays.
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Peak sales expectations remain at $1 billion for Recorlev by 2035 and $1 billion to $3 billion for XP-8121.
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Filed patent infringement lawsuits against two ANDA filers to defend four Orange Book-listed patents for Recorlev that extend to March 2040.
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Management expressed high confidence in their legal position and stated the litigation does not change their long-term commercial strategy or peak sales targets.
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The company maintains orphan drug exclusivity for Recorlev through the end of 2028 as a baseline layer of protection.
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Generic competition for Korlym is not viewed as a material risk to Recorlev due to the distinct clinical requirement for cortisol normalization.
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