Mirum(US:MIRM)2025-05-07 20:08Financial Performance - For the three months ended March 31, 2025, the company reported a net loss of $14.7 million, compared to a net loss of $25.3 million for the same period in 2024, indicating a 42% improvement in net loss year-over-year[113]. - Total revenue for the three months ended March 31, 2025, was $111.6 million, an increase of 61.2% compared to $69.2 million for the same period in 2024[135]. - Product sales, net increased to $111.6 million in Q1 2025 from $68.9 million in Q1 2024, driven by the commercialization of Livmarli and Bile Acid Medicines[136]. - The net loss for the three months ended March 31, 2025, was $14.7 million, a decrease of 42% compared to a net loss of $25.3 million in the same period in 2024[135]. - Interest income decreased to $3.0 million in Q1 2025 from $3.6 million in Q1 2024, primarily due to lower yields on investments[141]. Cash and Deficit - As of March 31, 2025, the company had an accumulated deficit of $658.9 million, up from $644.2 million as of December 31, 2024[113]. - The company had unrestricted cash, cash equivalents, and investments of $298.6 million as of March 31, 2025, compared to $292.8 million as of December 31, 2024[113]. - The accumulated deficit increased to $658.9 million as of March 31, 2025, compared to $644.2 million as of December 31, 2024[143]. - Net cash used in operating activities was $2.0 million for the three months ended March 31, 2025, reflecting a net loss of $14.7 million offset by adjustments of $24.0 million[162]. - Net cash provided by operating activities was $15.2 million for the three months ended March 31, 2024, reflecting a net loss of $25.3 million partially offset by adjustments of $16.5 million[163]. - Cash used in operating activities reflected changes in net operating assets of $11.3 million, primarily related to an increase in accounts receivable[162]. - Cash provided by operating activities reflected changes in net operating assets of $23.9 million, consisting primarily of a decrease in accounts receivables[163]. - The company maintains significant amounts of cash and cash equivalents at one financial institution that is in excess of federally insured limits[166]. Expenses - Research and development expenses rose to $46.0 million in Q1 2025, up 42.9% from $32.2 million in Q1 2024, primarily due to increased costs associated with product development and personnel[139]. - Selling, general and administrative expenses increased to $57.7 million in Q1 2025, a rise of 26.5% from $45.6 million in Q1 2024, mainly due to higher personnel costs and marketing expenses[140]. - The company anticipates an increase in research and development expenses as it continues to develop its product candidates, including volixibat and MRM-3379[123]. - Selling, general, and administrative expenses are expected to rise to support commercialization efforts and increased operational costs as a global biopharmaceutical public company[126]. Future Outlook - The company expects total product sales of its approved medicines to continue to increase annually, although revenue may experience fluctuations due to large periodic orders from partners[114][117]. - The company anticipates continued net losses as it invests in research, development, and commercialization activities for its product candidates[148]. - The company expects to satisfy future cash needs through existing capital, revenue from approved medicines, and potential equity offerings or collaborations[115]. - The company has entered into a Sales Agreement allowing for the potential sale of up to $200.0 million of common stock through an "at-the-market" offering[146]. Regulatory and Development Updates - The FDA granted orphan exclusivity for chenodiol for the treatment of cerebrotendinous xanthomatosis (CTX), with FDA approval received in February 2025 for commercialization under the brand name Ctexli[119]. - The company completed the acquisition of assets from Travere Therapeutics, primarily related to the development and commercialization of bile acid medicines, on August 31, 2023[108]. - The company initiated the Phase 3 EXPAND study for Livmarli in the fourth quarter of 2024, targeting rare cholestatic conditions[111]. Market Risk - The primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates[166]. - A near-term 10% fluctuation of the USD exchange rate could result in a potential change in the fair value of net assets and liabilities denominated in foreign currency by approximately $1.2 million[169]. - The company has outstanding $316.2 million aggregate principal of the Notes as of March 31, 2025, with a fair value of approximately $517.7 million[167].