Pacira(US:PCRX)2025-11-06 21:13Product Development and Acquisitions - Pacira's long-acting, non-opioid analgesic EXPAREL is approved for managing postsurgical pain in patients aged six years and older, with a unique pMVL drug delivery technology[199]. - The acquisition of Flexion Therapeutics in November 2021 added ZILRETTA, which provides major relief for osteoarthritis knee pain for up to three months[199]. - In February 2025, Pacira acquired an 81% equity interest in GQ Bio Therapeutics, enhancing its gene therapy capabilities with the novel HCAd platform[199]. - An exclusive license agreement with AmacaThera for AMT-143 includes a $5 million upfront payment and potential future milestone payments, aligning with Pacira's growth strategy[208]. - The company has prioritized three other preclinical HCAd-based gene therapy programs, including PCRX-1002 for Dry Eye Disease and PCRX-1003 for Degenerative Disc Disease[241]. Clinical Trials and Research - The company expects to report results from an interim analysis of the Phase 2 ASCEND study for PCRX-201 by the end of 2026[208]. - New data from a Phase 1 trial of PCRX-201 showed sustained efficacy for up to three years, with improvements in pain and function across all severity subgroups[209]. - The company is advancing a Phase 2 clinical study known as ASCEND for PCRX-201 in knee osteoarthritis (OA), involving approximately 135 patients aged 45 to 80[237]. - The primary endpoint of the ASCEND study includes the number and percentage of treatment-emergent adverse events from Week 1 through Week 52[239]. - A Phase 3 study is underway to evaluate ZILRETTA for managing OA pain of the shoulder, potentially expanding its label[219]. - Clinical data indicates that EXPAREL significantly reduces opioid usage while improving postsurgical pain management[215]. - The iovera° system is a non-opioid device providing pain relief for knee OA, with clinical data showing significant reductions in opioid use post-surgery[221][223]. - PCRX-201, targeting the IL-1 pathway, showed promising results in a Phase 1 study with over 70% of patients experiencing a 50% or greater improvement in pain[236]. Financial Performance - Net product sales for the three months ended September 30, 2025, were $178.0 million, a 6% increase from $167.7 million in 2024[244]. - Total revenues for the nine months ended September 30, 2025, were $529.5 million, a 3% increase from $513.7 million in 2024[244]. - EXPAREL revenue increased by 6% and 5% for the three and nine months ended September 30, 2025, respectively, driven by a 9% and 6% increase in gross vial volume[244]. - ZILRETTA revenue increased by 2% in the three months ended September 30, 2025, but decreased by 2% in the nine months due to a 4% decrease in kit volume[245]. - The cost of goods sold decreased by 12% to $34.3 million for the three months ended September 30, 2025, contributing to a gross margin increase to 81%[250]. - Total research and development (R&D) expenses increased by 36% to $25.966 million for the three months ended September 30, 2025, and by 38% to $79.859 million for the nine months ended September 30, 2025, compared to the same periods in 2024[254]. - Sales and marketing expenses grew by 35% to $58.471 million for the three months and by 36% to $165.006 million for the nine months ended September 30, 2025, reflecting investments in customer awareness and education programs[263]. - Total selling, general and administrative expenses increased by 23% to $91.797 million for the three months and by 25% to $267.151 million for the nine months ended September 30, 2025[262]. Legal and Regulatory Environment - The ongoing U.S. government shutdown may impact the FDA's ability to review regulatory submissions, potentially affecting Pacira's operations[206]. - The company expects to incur additional legal costs related to defending its intellectual property against two Chinese generic drug manufacturers seeking to produce a generic version of EXPAREL[266]. Workforce and Operational Changes - The company implemented a reduction in force affecting 71 employees, approximately 8% of the total workforce, resulting in $3.7 million in employee termination benefit charges[211]. - The workforce reduction is expected to lead to an annual reduction in operating expenses of approximately $13.0 million, excluding one-time expenses[212]. - In the nine months ended September 30, 2025, the company recognized $3.7 million in pre-tax employee termination benefit charges due to a reduction in force at its Science Center Campus[275]. Economic and Market Conditions - Global economic conditions, including inflation and tariffs, may negatively impact Pacira's business and financial results[201]. - The U.S. and E.U. agreed to a trade deal in July 2025, setting a 15% tariff on most imports from the E.U., which could affect costs for Pacira[202]. Debt and Financing - The company entered into a $300.0 million senior secured revolving credit facility on July 3, 2025, to refinance existing debt and provide working capital[298]. - The company entered into a TLA Credit Agreement on March 31, 2023, securing a term loan of $150.0 million, which is scheduled to mature on March 31, 2028[303]. - The TLA Term Loan requires quarterly principal repayments starting at $2.8 million, increasing to $3.8 million by March 31, 2025, with a balloon payment of approximately $85.3 million due at maturity[304]. - The company completed a private placement of $287.5 million in 2.125% convertible senior notes due 2029, with all principal outstanding as of September 30, 2025[306]. - The company repurchased $200.0 million of its 0.750% convertible senior notes due 2025 for $191.4 million, resulting in a $7.5 million gain on early extinguishment of debt[307]. - The company anticipates that existing cash and cash equivalents will be sufficient to fund operating expenses and capital requirements for the next 12 months[310]. - The company may require additional debt or equity financing to meet future operating and capital requirements, with no committed external sources of funds[311].