Mirum Pharmaceuticals (MIRM) Q2 2024 earnings summary

Executive summary

• Achieved Q2 2024 global net product sales of $77.8 million, up 139% year-over-year, driven by growth in LIVMARLI, Chenodal, and Cholbam, and supported by the Bile Acid Portfolio Acquisition.

• Net loss for Q2 2024 was $24.6 million, a significant improvement from $74.0 million in Q2 2023, reflecting higher product sales and absence of one-time losses.

• Secured key regulatory milestones, including NDA submission for Chenodal in CTX and label expansion for LIVMARLI in PFIC in the US and Europe.

• Positive interim results from volixibat studies in PSC (VISTAS) and PBC (VANTAGE), supporting continued development.

• Initiated Phase 3 EXPAND study for LIVMARLI in additional cholestatic pruritus indications.

Financial highlights

• Net product revenue reached $77.8 million in Q2 2024, up from $32.5 million in Q2 2023, with six-month sales at $146.7 million, up 138%.

• Total operating expenses were $102.1 million, including $32.7 million R&D, $49.2 million SG&A, $20.2 million cost of sales, and $17.7 million in non-cash charges.

• Net loss per share for Q2 2024 was $(0.52), improved from $(1.94) in Q2 2023.

• Cash, cash equivalents, and investments totaled $295.4 million as of June 30, 2024.

• $10 million milestone payment to Takeda upon FDA approval of LIVMARLI PFIC indication.

Outlook and guidance

• Full-year 2024 net product sales guidance maintained at $310–$320 million.

• Management expects continued annual growth in product sales for approved medicines.

• Sufficient liquidity to fund operations for at least the next 12 months, with ongoing investments in commercialization and clinical development.

• Expect international pricing reference impact to subside by Q4 2024, with demand growth flowing through to top line.

• Anticipate PFIC revenue contribution to be modest in 2024, with more significant impact expected in 2025.