Mirum(US:MIRM)2025-11-04 21:05Financial Performance - Net income for the three months ended September 30, 2025, was $2.9 million, compared to a net loss of $14.2 million for the same period in 2024[112]. - The company reported a net income of $2.9 million for the three months ended September 30, 2025, compared to a net loss of $14.2 million in 2024, indicating a significant turnaround[135]. - Total revenue for the three months ended September 30, 2025, was $133.0 million, compared to $90.4 million in 2024, marking a 47.2% increase[135]. - For the nine months ended September 30, 2025, net product sales were $372.4 million, a 57.0% increase from $237.0 million in the same period of 2024[146][147]. - Livmarli sales for the nine months ended September 30, 2025, were $253.6 million, up from $149.2 million in 2024, representing a 69.9% increase[148]. Cash and Investments - Unrestricted cash, cash equivalents, and investments increased to $378.0 million as of September 30, 2025, from $292.8 million as of December 31, 2024[112]. - As of September 30, 2025, the company had $378.0 million in unrestricted cash, cash equivalents, and investments, up from $292.8 million as of December 31, 2024[155]. - Net cash provided by operating activities was $49.8 million for the nine months ended September 30, 2025, compared to $15.4 million for the same period in 2024[171][174]. - Net cash used in investing activities was $25.0 million for the nine months ended September 30, 2025, significantly lower than $90.8 million for the same period in 2024[175][176]. - Net cash provided by financing activities was $31.1 million for the nine months ended September 30, 2025, compared to $12.4 million for the same period in 2024[177]. Expenses - Research and development expenses for the three months ended September 30, 2025, were $43.0 million, an increase of 35.4% from $31.7 million in 2024[140]. - Selling, general and administrative expenses rose to $61.9 million for the three months ended September 30, 2025, up 22.5% from $50.5 million in 2024[141]. - Selling, general and administrative expenses increased by $37.5 million to $182.9 million for the nine months ended September 30, 2025, primarily due to a $24.5 million rise in personnel and compensation-related expenses[151]. - Total operating expenses for the nine months ended September 30, 2025, were $389.9 million, compared to $300.9 million in 2024, reflecting a 29.0% increase[146]. Accumulated Deficit - The accumulated deficit as of September 30, 2025, was $661.8 million, up from $644.2 million as of December 31, 2024[112]. - The accumulated deficit increased to $661.8 million as of September 30, 2025, compared to $644.2 million as of December 31, 2024[155]. Product Development and Sales - The company expects total product sales of its approved medicines to continue increasing annually, despite potential fluctuations due to large periodic orders[113]. - The increase in net product sales was primarily driven by the continued commercialization of Livmarli, which generated $92.2 million in sales, up from $59.1 million in 2024, reflecting a 57.0% increase[136][137]. - The NDA for chenodiol for the treatment of cerebrotendinous xanthomatosis (CTX) was submitted in 2024, with FDA approval received in February 2025[108]. - The FDA granted Breakthrough Therapy Designation for volixibat as a potential treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC) in October 2024[110]. - The company completed the acquisition of assets from Travere Therapeutics, primarily related to the development and commercialization of chenodiol and Cholbam, on August 31, 2023[107]. - The company has entered into a license agreement for MRM-3379, an allosteric inhibitor of PDE4D, aimed at treating Fragile-X Syndrome[106]. Future Outlook - Research and development expenses are expected to increase as the company continues to develop volixibat and execute the EXPAND study for Livmarli[123]. - Selling, general and administrative expenses are anticipated to rise to support commercialization efforts and increased operational costs as a public company[125]. - The company anticipates continued net losses in the foreseeable future due to ongoing research and development efforts and commercialization activities[159]. - The company has $316.2 million in aggregate principal of Notes outstanding as of September 30, 2025, with a fixed interest rate[179]. - A near-term 10% fluctuation in the USD exchange rate could result in a potential change in the fair value of foreign currency-denominated net assets and liabilities by approximately $2.6 million[181].