Mirum(US:MIRM)2024-08-07 20:11Financial Performance - The net loss for the three months ended June 30, 2024, was $24.6 million, a decrease from $74.0 million for the same period in 2023, representing a 66.7% improvement [89]. - Total revenue for the three months ended June 30, 2024, was $77.9 million, an increase of $40.4 million (107.7%) compared to $37.5 million in the same period of 2023 [103]. - Product sales, net reached $77.8 million for the three months ended June 30, 2024, up $45.3 million (139.3%) from $32.5 million in the prior year, driven by sales of Bile Acid Medicines and Livmarli [104]. - The net loss for the three months ended June 30, 2024, was $24.6 million, a decrease of $49.4 million (66.8%) compared to a net loss of $74.0 million in the same period of 2023 [103]. - The company reported a net loss of $49.9 million for the six months ended June 30, 2024, partially offset by non-cash adjustments of $40.4 million [130]. Cash and Investments - The company had unrestricted cash, cash equivalents, and investments of $295.4 million as of June 30, 2024, compared to $286.3 million at the end of 2023 [89]. - As of June 30, 2024, the company had $295.4 million in unrestricted cash and investments, up from $286.3 million as of December 31, 2023 [125]. - Cash and cash equivalents as of June 30, 2024, included significant amounts at one financial institution exceeding federally insured limits [134]. Expenses - Research and development expenses increased to $32.7 million for the three months ended June 30, 2024, a rise of $10.7 million (48.6%) compared to $22.0 million in the same period of 2023 [108]. - Selling, general and administrative expenses were $49.2 million for the three months ended June 30, 2024, an increase of $16.3 million (49.2%) from $32.9 million in the same period of 2023 [109]. - Research and development expenses totaled $64.9 million for the six months ended June 30, 2024, an increase of $19.3 million compared to $45.6 million in the same period of 2023 [119]. - Selling, general and administrative expenses increased to $94.8 million for the six months ended June 30, 2024, up from $63.1 million in the same period of 2023, reflecting higher personnel and marketing costs [120]. - Total operating expenses for the three months ended June 30, 2024, were $102.1 million, an increase of $40.3 million (65.2%) compared to $61.8 million in the same period of 2023 [103]. Acquisitions and Milestones - The Bile Acid Portfolio Acquisition from Travere Therapeutics was completed on August 31, 2023, with an upfront payment of $210.4 million and potential milestone payments of up to $235.0 million [90]. - The Bile Acid Portfolio Acquisition was completed for up to $445.0 million, with $210.4 million paid at closing and additional payments contingent on sales milestones [125]. - The company has accrued or paid aggregate development, regulatory, and sales milestones of $91.0 million related to Livmarli and volixibat programs under the Shire License Agreement [92]. Clinical Trials and Product Development - Positive topline data from the RESTORE clinical trial for Chenodal in patients with cerebrotendinous xanthomatosis (CTX) was reported in October 2023, with a new drug application submitted to the FDA in June 2024 [86]. - Interim results from the VANTAGE Phase 2b clinical trial for volixibat showed a statistically significant improvement in pruritus with a placebo-adjusted difference of -2.32 points [88]. - The most common adverse event for volixibat was diarrhea, occurring in 77% of patients, all classified as mild to moderate [88]. - The company expects total product sales of its approved medicines to continue increasing annually, driven by ongoing commercialization efforts [92]. Revenue Changes - License and other revenue was $0.1 million for the three months ended June 30, 2024, a decrease of $4.9 million (98.0%) compared to $5.0 million in the same period of 2023 [106]. - License and other revenue decreased to $0.4 million for the six months ended June 30, 2024, down from $7.5 million in the same period of 2023 [116]. Debt and Financial Position - As of June 30, 2024, the company had outstanding $316.3 million aggregate principal of Notes, with a fair value of approximately $424.4 million [134]. - Interest expense decreased to $3.6 million for the three months ended June 30, 2024, down $0.2 million (5.3%) from $3.8 million in the same period of 2023 [111]. - Interest income rose to $7.1 million for the six months ended June 30, 2024, an increase of $1.2 million compared to the same period in 2023 [122]. Operational Changes - The company experienced a $20.9 million change in net operating assets, including a $7.5 million decrease in accounts receivable and an $18.2 million increase in accounts payable [130]. - The company has identified material weaknesses in internal controls over financial reporting as of June 30, 2024, which are being addressed through a remediation plan [139]. - Inflation has not significantly impacted the company's results of operations for the periods presented [136].