Summary of Risks Associated with Our Business Summary of Risks Key business risks include the commercial success of medicines, reliance on third parties, clinical development uncertainty, and competition - Commercial success hinges on marketing approved medicines and is subject to market acceptance and reliance on third-party manufacturing8 - The business depends on the success of product candidates in lengthy and expensive clinical testing with uncertain outcomes8 - The company faces significant competition and may require substantial additional financing for commercialization and development8 - Reliance on licensed intellectual property and the ability to maintain IP protection are critical to the business8 PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Unaudited financial statements show significant revenue growth and a reduced net loss, driven by strong product sales Condensed Consolidated Balance Sheets Total assets grew to $725.8 million, supported by increases in cash and receivables, alongside a rise in liabilities and stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Current Assets | $453,398 | $392,788 | | Cash and cash equivalents | $228,122 | $222,503 | | Accounts receivable | $106,836 | $78,286 | | Total Assets | $725,825 | $670,754 | | Total Current Liabilities | $144,796 | $126,551 | | Total Liabilities | $470,667 | $445,114 | | Total Stockholders' Equity | $255,158 | $225,640 | Condensed Consolidated Statements of Operations Total revenue increased 64% year-over-year to $127.8 million, significantly narrowing the quarterly net loss to $(5.9) million Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | 6 Months 2025 | 6 Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $127,785 | $77,875 | $239,370 | $147,097 | | Product sales, net | $127,785 | $77,760 | $239,370 | $146,677 | | Total Operating Expenses | $132,774 | $102,107 | $259,542 | $197,797 | | Cost of sales | $23,421 | $20,227 | $46,439 | $38,057 | | Research and development | $46,067 | $32,672 | $92,111 | $64,894 | | Selling, general and administrative | $63,286 | $49,208 | $120,992 | $94,846 | | Loss from Operations | $(4,989) | $(24,232) | $(20,172) | $(50,700) | | Net Loss | $(5,861) | $(24,638) | $(20,538) | $(49,917) | | Net Loss Per Share | $(0.12) | $(0.52) | $(0.42) | $(1.06) | Condensed Consolidated Statements of Cash Flows Net cash from operations was $10.1 million, and the company's cash position increased by $5.7 million to $228.6 million Cash Flow Summary for Six Months Ended June 30 (in thousands) | Category | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $10,079 | $11,409 | | Net cash used in investing activities | $(22,733) | $(72,730) | | Net cash provided by financing activities | $15,047 | $8,496 | | Net increase (decrease) in cash | $5,674 | $(52,831) | | Cash at end of period | $228,602 | $233,495 | Notes to Unaudited Condensed Consolidated Financial Statements Notes detail strong product sales growth, intangible asset composition, and the convertibility status of senior notes - The company has three approved medicines: LIVMARLI® (maralixibat), Cholbam® (cholic acid), and Chenodal®/Ctexli® (chenodiol)23 Product Sales, Net by Medicine (in thousands) | Product | Q2 2025 | Q2 2024 | 6 Months 2025 | 6 Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Livmarli | $88,160 | $47,231 | $161,384 | $90,076 | | Bile Acid Medicines | $39,625 | $30,529 | $77,986 | $56,601 | | Total | $127,785 | $77,760 | $239,370 | $146,677 | Product Sales, Net by Geography (in thousands) | Region | Q2 2025 | Q2 2024 | 6 Months 2025 | 6 Months 2024 | | :--- | :--- | :--- | :--- | :--- | | United States | $95,532 | $65,080 | $182,454 | $121,191 | | Rest of the world | $32,253 | $12,680 | $56,916 | $25,486 | | Total | $127,785 | $77,760 | $239,370 | $146,677 | - The 4.00% Convertible Senior Notes due 2029 became convertible at the option of holders as the stock price condition was met81 Management's Discussion and Analysis of Financial Condition and Results of Operations Management attributes revenue growth to Livmarli and Bile Acid Medicines sales, while rising operating expenses reflect increased commercial and R&D activities Results of Operations Q2 2025 product sales grew by $50.0 million, driven by Livmarli, alongside increased R&D and SG&A expenses - The increase in product sales for Q2 2025 was driven by continued commercialization of Livmarli and sales of Bile Acid Medicines, including an $11.0 million positive change in estimate135 - R&D expenses increased primarily due to higher spending on volixibat and MRM-3379 programs and a $10.2 million increase in personnel costs139143 - SG&A expenses rose mainly due to an $8.9 million increase in personnel-related expenses to support commercial activities140 Liquidity and Capital Resources The company holds $321.7 million in unrestricted cash and investments, deemed sufficient to fund operations for at least 12 months - The company had $321.7 million of unrestricted cash, cash equivalents and investments as of June 30, 2025, sufficient to fund operations for at least the next 12 months152156 - The company has an effective automatic shelf registration and a $200.0 million ATM offering program, neither of which had been used as of June 30, 2025154155 - Holders of the convertible notes have the option to convert their notes during Q3 2025, which the company may settle in cash, stock, or a combination163 Quantitative and Qualitative Disclosures About Market Risk The company's primary market risks are interest rate fluctuations on its investments and foreign currency exposure, mainly to the Euro and Swiss Franc - The company's primary market risk exposures are interest rate sensitivity on its cash and investments and foreign currency exchange rate risk174176 - A hypothetical 10% fluctuation of the USD exchange rate could result in a potential change of approximately $1.6 million in the fair value of net assets and liabilities denominated in foreign currency177 Controls and Procedures Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - Management concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective178 - No material changes to the company's internal control over financial reporting occurred during the three months ended June 30, 2025180 PART II. OTHER INFORMATION Legal Proceedings The company is not currently involved in any legal proceedings expected to have a material adverse effect on its financial condition - Management believes there are currently no pending claims or actions that could have a material adverse effect on the company's results of operations, financial condition, or cash flows182 Risk Factors Key risks include commercialization challenges, dependence on third parties, competition, intellectual property vulnerabilities, and future financing needs - Risks to commercialization include the ability to profitably market approved medicines, achieve market acceptance, and secure adequate reimbursement from payors184186191 - The business is highly dependent on third parties for manufacturing, distribution, and conducting clinical trials, creating risks of disruption and delays320324 - The company faces significant competition from other pharmaceutical companies, including those with greater resources or developing similar treatments267268 - Intellectual property risks include the lack of composition-of-matter patents for Livmarli and reliance on method-of-use patents363379 - Financial risks include the need for substantial additional financing and potential dilution to stockholders from equity offerings or note conversions341346 Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities during the covered period - There were no sales of unregistered equity securities during the quarter472 Exhibits This section lists exhibits filed with the Form 10-Q, including required CEO and CFO certifications and XBRL data files - Exhibits filed include CEO and CFO certifications pursuant to Sarbanes-Oxley Sections 302 and 906, and Inline XBRL documents476
Mirum(MIRM) - 2025 Q2 - Quarterly Report