MannKind(MNKD) - 2025 Q3 - Quarterly Report

Financial Position - As of September 30, 2025, the company had cash, cash equivalents, and investments totaling $286.3 million, with an accumulated deficit of $3.2 billion and a total stockholders' deficit of $44.6 million[221]. - As of September 30, 2025, the company had $66.0 million in insulin purchase commitments and $111.3 million in outstanding debt[259]. - The company expects to meet its liquidity needs for at least the next 12 months based on current cash, cash equivalents, and investments totaling $286.3 million[275]. - Total principal amount of outstanding borrowings as of September 30, 2025, was $111.3 million, which does not include the recent acquisition-related borrowings[274]. Revenue and Sales Performance - For the three months ended September 30, 2025, total revenues increased by $12.1 million, or 17%, to $82.1 million compared to the same period in 2024[226]. - Net revenue from commercial product sales for the three months ended September 30, 2025, increased by $2.6 million, or 13%, to $22.3 million compared to the same period in 2024[226]. - Royalty revenue from United Therapeutics (UT) increased by $6.2 million, or 23%, for the three months ended September 30, 2025, due to UT's increase in net revenue from sales of Tyvaso DPI[233]. - Gross revenue from sales of Afrezza increased by $3.0 million, or 13%, for the three months ended September 30, 2025, primarily driven by increased price and higher demand[227]. - Commercial product sales increased by $4.46 million, or 8%, to $63.73 million for the three months ended September 30, 2025, compared to $59.27 million in the prior year[235]. Expenses - Total expenses increased by $5.92 million, or 10%, for the three months ended September 30, 2025, totaling $63.23 million compared to $57.32 million in the prior year[237]. - Research and development expenses increased by $1.1 million, or 9%, for the three months ended September 30, 2025, driven by continued patient enrollment in clinical studies[238]. - Selling, general and administrative expenses increased by $5.17 million, or 22%, for the three months ended September 30, 2025, primarily due to higher headcount and Afrezza promotional costs[241]. Profitability - GAAP reported net income for the three months ended September 30, 2025, was $7.985 million, with a basic EPS of $0.03, compared to $11.550 million and $0.04 for the same period in 2024[255]. - Non-GAAP adjusted net income for the nine months ended September 30, 2025, was $57.977 million, with a basic EPS of $0.19, compared to $44.760 million and $0.16 for the same period in 2024[255]. Cash Flow - Cash generated from operating activities for the nine months ended September 30, 2025, was $26.2 million, compared to $19.9 million for the same period in 2024[265][269]. - Cash used in investing activities for the nine months ended September 30, 2025, was $12.8 million, primarily due to the issuance of a note receivable and the purchase of debt securities[270]. Acquisitions and Investments - The company acquired scPharmaceuticals Inc. in October 2025, with the commercial launch of Furoscix for chronic heart failure commencing in Q1 2023[219]. - The company completed the acquisition of scPharma in October 2025, incurring $3.7 million in incremental costs associated with the transaction[242]. - The maximum aggregate amount payable with respect to the CVRs issued in the scPharma acquisition is $59.7 million, contingent on achieving certain milestones[262]. Other Financial Metrics - Interest income, net decreased by $0.55 million, or 17%, for the three months ended September 30, 2025, totaling $2.63 million compared to $3.18 million in the prior year[244]. - Impairment of available-for-sale investment was $6.41 million for the three and nine months ended September 30, 2025, resulting from the write-off of the Thirona investment[249]. - Loss on settlement of debt was $7.1 million for the nine months ended September 30, 2024, related to the repayment of the MidCap credit facility and Mann Group convertible note[250]. - Total other expense for the nine months ended September 30, 2025 was $24.15 million, a slight increase of $0.13 million compared to the prior year[244]. - For the nine months ended September 30, 2025, the company realized a currency loss of $7.8 million due to fluctuations in the Euro exchange rate[278]. - A hypothetical 10% change in the U.S. dollar to Euro exchange rate on September 30, 2025, would have impacted pre-tax income by approximately $6.6 million[279]. Research and Development - The company initiated a global Phase 3 registrational study of inhaled clofazimine in 2024, with enrollment expected to continue into 2026[218].