Mirum(MIRM) - 2025 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenues for the second quarter reached $128 million, representing a 64% increase compared to the same quarter last year [6][19] - The company raised its full-year revenue guidance for 2025 to a range of $490 million to $510 million, indicating nearly 50% top-line growth [6][13] Business Line Data and Key Metrics Changes - Net product sales for Lidmarley were approximately $128 million, driven by strong demand in both the U.S. and international markets [10] - In the U.S., Lidmarley generated about $57 million in net product sales, with increased patient awareness contributing to higher volumes [11][12] - Internationally, Lidmarley sales reached $31 million, supported by expanding reimbursement and strong demand [12][13] - The bile acid portfolio contributed approximately $40 million in revenue, benefiting from steady demand [13] Market Data and Key Metrics Changes - The U.S. market for Lidmarley is seeing increased recognition of PFIC diagnoses, with more patients presenting later in childhood or adulthood [11] - The company is experiencing durable growth in international markets, particularly with the recent launch of Lidmarley in Japan [12] Company Strategy and Development Direction - The company’s strategy focuses on commercial execution, scientific innovation, and financial discipline, with ongoing progress in all areas [6] - The pipeline includes three late-stage milestones, with significant studies expected to report data in the next 24 months [7][15] - Lidmarley is positioned to potentially become a billion-dollar revenue brand, driven by growth in Alagille syndrome and PFIC indications [14][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing momentum of commercial medicines and the pipeline, highlighting the potential for significant patient impact [5][21] - The company is optimistic about the upcoming clinical milestones and the overall growth trajectory [7][19] Other Important Information - The company reported operating cash flow positivity for the quarter, with cash and investments totaling $322 million [20] - The cash contribution margin from the commercial business exceeded 50% in the second quarter [20] Q&A Session Summary Question: What are the overall therapy persistence rates for Lidmarley? - Management indicated that persistence rates for Alagille syndrome are stable, with approximately 70-75% of patients remaining on therapy after one year [25][26] Question: Can you provide details on expected revenue distribution between Lidmarley and the bile acid business? - Management did not break down guidance by specific products but noted that trends observed year-to-date are expected to continue [33] Question: What are the main drivers of growth in Lidmarley sales? - Key drivers include increased awareness of PFIC and the introduction of a single tablet formulation, which has received positive feedback [37][38] Question: Any insights on inventory impacts in Q2 and Takeda order cadence? - Inventory impacts are primarily relevant in Japan, with expectations of periodic orders from Takeda leading to quarter-to-quarter variability [42][43] Question: What is the status of the Fragile X study? - The company has received clearance from the FDA and is on track to initiate the Phase II study by the end of the year [48] Question: How well penetrated is the company in the Alagille and PFIC markets? - Management estimates approximately 50% penetration in the Alagille market, with ongoing efforts to increase awareness and patient identification in PFIC [55][56] Question: Are any patients in the EXPAND study already on Lidmarley through compassionate use? - The EXPAND study is designed for patients who have not previously been treated, with strong interest from patient populations [61]