Revenue Performance - Net revenue for the three months ended March 31, 2025, decreased by $18 million, or 6%, to $266 million compared to $284 million in the prior year period[97] - U.S. net revenue decreased by 8% to $222 million in Q1 2025 from $241 million in Q1 2024, primarily due to increased competition and lower pricing for SUBOXONE Film[98] - SUBLOCADE accounted for 66% of net revenue in Q1 2025, down from 63% in Q1 2024, while other buprenorphine-based products accounted for 32% in Q1 2025, down from 33% in Q1 2024[93] Financial Metrics - Gross margin decreased to 83% in Q1 2025 from 87% in Q1 2024, reflecting unfavorable manufacturing variances in the current period[103] - Net cash provided by operating activities was $75 million in Q1 2025, an increase of $112 million compared to a net cash used of $37 million in Q1 2024[111] - Total cash and investments increased to $400 million as of March 31, 2025, from $347 million as of December 31, 2024[109] Expenses and Investments - Research and development expenses decreased by $5 million, or 19%, to $22 million in Q1 2025, as the company refocused its development pipeline[105] - The company expects capital expenditures of approximately $50 million to $70 million in 2025, primarily for the SUBLOCADE suite at the Raleigh Manufacturing Facility[113] - Capital expenditures for the three months ended March 31, 2025, were $5 million, primarily for the expansion of the Raleigh Manufacturing Facility[118] Liabilities and Cash Needs - Current liabilities exceed current assets by $122 million, and total liabilities exceed total assets by $285 million[115] - The company anticipates meeting its cash needs for at least the next twelve months through existing cash, operations, and debt[116] - The company has a focus on litigation settlement payments and debt repayments as part of its cash requirements[119] Regulatory and Development Updates - The FDA approved label changes for SUBLOCADE on February 24, 2025, allowing for a rapid initiation protocol and alternative injection sites[94] - The INDV-2000 Phase 2 proof of concept study's last subject visit is now expected in the first half of 2026, delayed from late 2025 due to lower than expected enrollment[121] Contingent Liabilities and Market Risk - The company is subject to contingent liabilities as described in its financial statements[117] - No material changes in market risk have occurred since the last annual report[124] - As of March 31, 2025, no material changes to contractual obligations have occurred beyond the ordinary course of business[119] Sales Volume and Liquidity - The company needs to sustain sales volume performance to maintain necessary liquidity in the near term[116] - The company is investing in capital expenditures to support its manufacturing capabilities[118]
Indivior PLC(INDV) - 2025 Q1 - Quarterly Report