Achieved a defining milestone of financial self-sustainability, effectively removing the need for external funding to support the current strategy and pipeline.

Recorlev served as the primary growth engine, nearly doubling its patient base to approximately 700 patients by year-end 2025.

Gvoke provided durable and predictable revenue growth of 14% for the full year, supported by broad market access and alignment with treatment guidelines.

Keveyis outperformed expectations by increasing the average number of patients on therapy through comprehensive patient support services.

Operating leverage improved significantly, enabling the company to report its first full year of net income and nearly $60 million in adjusted EBITDA.

Management attributes the 44% full-year revenue growth to disciplined execution and broad-based demand across all three commercial products.

The company doubled its Recorlev commercial footprint in January 2026 to scale patient support and sales interactions for long-term growth.

2026 revenue guidance of $375 million to $390 million assumes over 30% growth driven primarily by continued Recorlev expansion.

Phase III initiation for XP-8121 is planned for the second half of 2026, requiring a $25 million step-up in R&D investment.

Management expects to remain adjusted EBITDA positive in 2026 despite significant increases in R&D and a $45 million increase in SG&A spending.

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.

Peak sales expectations remain at $1 billion for Recorlev by 2035 and $1 billion to $3 billion for XP-8121.

Filed patent infringement lawsuits against two ANDA filers to defend four Orange Book-listed patents for Recorlev that extend to March 2040.

Management expressed high confidence in their legal position and stated the litigation does not change their long-term commercial strategy or peak sales targets.

The company maintains orphan drug exclusivity for Recorlev through the end of 2028 as a baseline layer of protection.

Generic competition for Korlym is not viewed as a material risk to Recorlev due to the distinct clinical requirement for cortisol normalization.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here.

Management doubled the commercial team to manage the complexity of bringing rare disease patients onto therapy and keeping them there.

Future expansions will be scaled based on patient load, with consistent investment expected over the next several years.

The litigation was anticipated and does not increase the urgency for M&A to hedge product concentration risk.

The company's improved balance sheet provides the capacity for business development, but management emphasized they do not 'have' to do deals to succeed.

The primary gating factor is technical: ensuring the Phase III trial uses the final commercial-scale formulation and delivery device.

Management confirmed they are fully aligned with the FDA on the clinical path and do not face further regulatory hurdles before starting the trial.

Gross margins reached 87% in Q4, and management expects continued modest improvement as the product mix shifts toward higher-margin therapies.

Gross-to-net dynamics have stabilized, with no material movements expected across the portfolio in 2026.

One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.