Mirum Pharmaceuticals, Inc. Q3 FY2026 earnings call

• Commercial Strength: The company is approaching its eighth anniversary with four approved medicines and a commercial business generating nearly $300 million in annualized net product sales.
• Product Launches: Atebrios was approved in September for adults and pediatric FOP patients (ages 12+) with a U.S. launch commencing in October. Early engagement from patients and caregivers has been strong.
• Pipeline Progress: Positive Phase 3 data reported for Brilovitug (Velixivat) in PSC and Hepatitis Delta (HDV). EXPAND study for Livmarlie showed positive results in biliary atresia.
• Regulatory Milestones: Five potential regulatory submissions are planned for the first half of 2027, including NDAs for Velixivat (PSC/PBC), a BLA for Verlovatog (HDV), an SNDA for Livmarlie, and a label expansion for Atebrios in younger children.
• Financial Health: Cash contribution margin from commercial business was in the high 50s percent of sales. R&D expense was approximately $94 million on a cash basis, representing about 50% of revenues. Cash, equivalents, and investments stood at approximately $500 million as of September.

Net product sales for the third quarter were $186 million, compared to $133 million in Q3 2025. Marley remains the primary growth driver with $133 million in net product sales (including $100 million in the U.S.). Bioasset medicines generated $52 million in net product sales. Livmarlie continues to show steady growth driven by Allergy Yield Syndrome uptake and PFIC diagnosis improvements. Atebrios launched in October for FOP patients.

• Full-Year Net Product Sales: Increased guidance to $715–$720 million, up from previous estimates. This revision reflects strong performance through the first nine months ($522 million), which already equals full-year 2025 revenue.
• Quarterly Growth Trajectory: Management expects total revenue growth to continue at a cadence of $10–$15 million per quarter throughout 2027, driven largely by adult PFIC growth for Livmarlie.
• R&D Spend Expectations: Management expects current levels of R&D spend (approx. 50% of revenue) to continue for approximately two more quarters before potentially declining as key late-stage trials complete.

• Regulatory Uncertainty: Previous interactions with the FDA regarding the PSC program (VISTA study) have been complex, though management expresses confidence in the robustness of the data sets for upcoming submissions.
• Market Access and Diagnosis: Significant portions of addressable patient populations for diseases like PFIC and HDV remain undiagnosed. Success depends on increasing awareness, genetic testing adoption, and provider education.
• Competitive Landscape: While currently no generic entrants have appeared in the bile acid franchise, management acknowledges that exclusivity periods expire over time, requiring ongoing vigilance.
• Operational Execution: Managing multiple simultaneous regulatory submissions (NDAs/BLAs) in H1 2027 requires significant organizational bandwidth and careful resource allocation to avoid execution errors.

Q: Analyst asked about the drivers of raised guidance and if PSC IBD subgroup data had been previously submitted to the FDA. / A: CFO Peter Radovich identified adult PFIC growth as the biggest driver, noting a persistent $10–15M quarterly step-up trend expected through next year. CEO Chris Peetz clarified that the PSC IBD data presented at ASLD are new, detailed analyses not previously seen by the FDA, intended to build familiarity rather than seek immediate alignment.

Q: Analyst inquired about the potential for BD activity during this busy submission period and the types of assets targeted. / A: CEO Chris Peetz stated that while the team is organized to handle the H1 2027 submission workload without issue, they remain opportunistic. President Peter Radovich added that they look broadly at rare disease assets across clinical and commercial stages, leveraging their specific expertise in patient finding, access, and regulatory navigation to add value to underappreciated opportunities.

Q: Analyst asked about differentiating features of Belovatug in the HDV market and the launch cadence for Livmarlie's VA indication. / A: CEO Chris Peetz highlighted Belovatug’s fully human antibody mechanism capable of driving deepening virologic suppression and ALT normalization over time, supported by two-year data presentations at ASLD. For Livmarlie’s VA indication, Peter Radovich noted that patients are already at centers prescribing Livmarlie for other indications, creating a captive audience ready for rapid therapy initiation upon approval.

Q: Analyst questioned the confidence in the timing of the PSC NDA submission given past FDA challenges. / A: CEO Chris Peetz reaffirmed confidence in submitting the NDA in the first half of next year, citing robust datasets and recent safety analyses being prepared. He noted that interactions are focused on building FDA familiarity with the extensive data package rather than seeking formal pre-submission alignment, contrasting this with older interactions from 2019-2020.

Q: Analyst asked about the expected launch trajectory for Atebrios compared to Marley and any signs of slowing early adoption. / A: President Peter Radovich indicated that early adoption and inbound interest for Atebrios have been very strong, expecting a faster adoption curve than Marley. CEO Chris Peetz added that the overall revenue growth cadence of $10–15M per quarter is expected to continue into next year, suggesting no immediate slowdown in portfolio momentum.