iovera°
Search documents
Pacira BioSciences Appoints Samit Hirawat, M.D., to Board of Directors
Globenewswire· 2026-01-28 13:00
Core Insights - Pacira BioSciences, Inc. has appointed Dr. Samit Hirawat to its Board of Directors, expanding the board to 10 members [1][2] Company Overview - Pacira is focused on delivering innovative, non-opioid pain therapies aimed at transforming patient lives [4] - The company has three commercial-stage non-opioid treatments: EXPAREL, ZILRETTA, and iovera® [4] - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications [4] - ZILRETTA is an extended-release injectable for managing osteoarthritis knee pain [4] - iovera® is a handheld device providing immediate, long-acting, drug-free pain control [4] - Pacira is advancing a pipeline of clinical-stage assets, including PCRX-201, a gene therapy in Phase 2 development for knee osteoarthritis [4] Leadership and Expertise - Dr. Hirawat brings over 25 years of clinical development and industry expertise, previously serving as Chief Medical Officer at Bristol Myers Squibb [2][3] - His experience includes overseeing global drug development and advancing transformative therapies across various therapeutic areas [2] - Dr. Hirawat has a strong academic background with over 150 peer-reviewed publications [3]
Pacira BioSciences, Inc. (PCRX) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-14 22:06
Company Overview - Pacira's mission is to deliver innovative non-opioid pain management therapies to transform lives, focusing on patient-centered care, scientific integrity, and employee well-being [3] - The company reported unaudited sales of $726 million for the previous year and has over 800 engaged employees [3] - Pacira has helped more than 18 million patients to date [3] Product Portfolio - The flagship product of Pacira is EXPAREL, a nerve block solution [4] - Other products include ZILRETTA, a long-acting corticosteroid for osteoarthritis pain, and iovera°, a medical device utilizing cryoneurolysis for pain management [4] Patient Impact - The company highlights success stories, such as a Division 1 soccer player who opted for a non-opioid solution due to family issues with opioid abuse, demonstrating the effectiveness of their products [5]
Pacira BioSciences (NasdaqGS:PCRX) FY Earnings Call Presentation
2026-01-14 19:15
JP Morgan 44th Annual Healthcare Conference Frank D. Lee Chief Executive Officer PCRX | January 14, 2026 Forward-looking statements and where to find additional information Any statements in this presentation about Pacira's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "anticipate," "believe," "can," "could," "estimate," "expect," "intend," "may," "plan," "project," "should," "will," "would," and similar expressions, constitute forward-look ...
Pacira Announces Agreement with LG Chem to Make EXPAREL® Available in Select Asian-Pacific Markets
Globenewswire· 2026-01-13 13:00
Core Insights - Pacira BioSciences has partnered with LG Chem to expand access to opioid-sparing postsurgical pain control in select Asia-Pacific markets through the exclusive commercialization of EXPAREL [1][2] Company Overview - Pacira BioSciences is focused on delivering innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera® [3] - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management techniques [3] - ZILRETTA is an extended-release injectable for osteoarthritis knee pain management [3] - Iovera® is a handheld device providing immediate, long-acting, drug-free pain control [3] - The company is advancing a pipeline of clinical-stage assets, including PCRX-201, a gene therapy for osteoarthritis of the knee in Phase 2 development [3] Partnership Details - LG Chem will have exclusive rights to commercialize EXPAREL in the designated territories, leveraging its experience in orthopedic pain management [2] - Pacira will receive an undisclosed upfront payment, a transfer price, and tiered royalties on future sales by LG Chem [2] - LG Chem is responsible for obtaining regulatory approvals in the licensed territories, with plans to file for marketing authorizations in South Korea and Thailand within six months [2]
Pacira Reports Preliminary Unaudited Fourth Quarter and Full-Year 2025 Revenues
Globenewswire· 2026-01-08 21:01
Core Insights - Pacira BioSciences reported record-high total revenue of $726.4 million for the year ended December 31, 2025, representing an increase from $701.0 million in 2024, driven by strong sales of EXPAREL and share repurchase activities [1][4][6] Revenue Highlights - Fourth quarter EXPAREL net product sales reached $155.8 million in 2025, up from $147.7 million in 2024, with a volume growth of 7 percent [8] - Full-year EXPAREL net product sales were $575.1 million in 2025, compared to $549.0 million in 2024, reflecting a 6 percent volume growth [8] - Fourth quarter ZILRETTA net product sales were $33.0 million in 2025, slightly down from $33.1 million in 2024 [8] - Fourth quarter iovera° net product sales increased to $7.0 million in 2025 from $6.5 million in 2024 [8] - Other revenue, including sales of bupivacaine liposome injectable suspension, was $1.1 million in the fourth quarter of 2025, compared to zero in the same period of 2024 [8] Share Repurchase Program - During the fourth quarter of 2025, the company repurchased 2.0 million shares of its common stock for $50.0 million, with $150.0 million remaining on its current share repurchase authorization [6] Strategic Outlook - The CEO emphasized the company's solid execution and progress in advancing its strategic priorities, positioning it for sustainable long-term success and significant revenue growth moving forward [2]
Pacira BioSciences Announces Results From 12-Month Pilot Study Demonstrating Favorable Safety and Significant Improvements in Pain With iovera° Compared to Radiofrequency Ablation in Chronic Low Back Pain
Globenewswire· 2025-12-02 13:00
Core Insights - The study published in Pain Physician shows that iovera° cryoneurolysis significantly improves functional outcomes for chronic low back pain patients compared to radiofrequency ablation (RFA) [1][6] - Patients treated with iovera° experienced lower pain scores and improved functional disability over a 12-month period [8] Study Findings - The pilot study involved 30 patients with facet-mediated chronic low back pain, comparing iovera° to RFA [4] - At 180 days, pain scores for iovera° patients were 3.1 compared to 5.4 for RFA patients (p=0.01) [8] - At 360 days, pain scores for iovera° patients were 3.0 compared to 6.1 for RFA patients (p=0.01) [8] - Functional disability, measured by the Oswestry Disability Index (ODI), showed iovera° patients scoring 10.1 at 360 days versus 20.6 for RFA patients (p=0.002) [8] - Fewer iovera° patients required additional spine injections after 180 days, with 45.5% needing further treatment compared to 75% of RFA patients [8] - No treatment-related adverse events were reported in either group during the 12-month follow-up [8] Treatment Mechanism - The iovera° system utilizes cryoneurolysis, applying focused cold therapy to targeted nerves to interrupt pain signal transmission [2][8] - Pain relief is typically immediate and can last up to 90 days as the nerve regenerates [2][9] Industry Context - Chronic low back pain is a leading cause of disability in the U.S. and contributes significantly to opioid use [3] - The need for alternative, tissue-sparing approaches like cryoneurolysis is underscored by the potential tissue damage associated with RFA [3] - The FDA recently cleared a new SmartTip for iovera° to allow deeper nerve access for lumbar applications, supporting ongoing clinical evidence expansion [6]
Pacira(PCRX) - 2025 Q3 - Earnings Call Presentation
2025-11-06 21:30
Business Growth - Pacira treated more than 3 million patients per year[4,6,8] - The company is experiencing double-digit compounded annual growth rate in product revenue[4,9] - EXPAREL volume growth in 3Q25 reached 9% year-over-year, marking the highest volume growth in over 3 years[9] - Pacira anticipates product revenue to exceed $1.1 billion by 2030[9] Profitability - Pacira achieved a 5-percentage point gross margin improvement over 2024[4,10] - The company's non-GAAP gross margins are projected to be between 80% and 82%[11,42] Pipeline and Partnerships - Pacira is expanding its clinical pipeline with 5 novel programs in development[4,12] - The company is establishing 5 partnerships, including pipeline and commercial agreements[4,14] Financial Performance - Total revenue for 3Q25 was $180 million[42] - Adjusted EBITDA for 3Q25 was $49 million[42] - The company's cash and investments stand at approximately $246 million[42]
Pacira(PCRX) - 2025 Q2 - Earnings Call Presentation
2025-08-05 20:30
Financial Performance & Strategy - Pacira reported Q2 2025 total revenue of $181 million[42] - The company is transitioning into an innovative biopharmaceutical organization, aiming to lead in musculoskeletal pain and adjacencies[5] - Pacira updated its 2025 total revenue guidance to $730-750 million[42] - Non-GAAP gross margins were 82% in Q2 2025[42], with a new range projected at 78-80%[10] - Adjusted EBITDA for Q2 2025 was $54 million[42] - The company has approximately $270 million in cash and investments[41,42] Product & Pipeline Development - Over 3 million patients are treated per year with Pacira's products[4] - EXPAREL's intellectual property is strengthened with two new patents listed in the FDA's Orange Book, providing exclusivity into 2040+[16] - Two registrational studies for ZILRETTA in shoulder OA and iovera° in spasticity are progressing as planned[20] - The Phase 2 ASCEND Part A study for PCRX-201 has surpassed 50% enrollment[22] Market Access & Commercial Growth - Over 40 million commercial lives have access to EXPAREL via separate reimbursement as of Q2 2025[29], with ~100 million total covered lives expected by year end[29] - The company signed a 3rd GPO in Q2 2025, increasing procedural volumes of EXPAREL business under contract[31]
Pacira BioSciences Reports Second Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-05 20:00
Core Insights - Pacira BioSciences reported solid execution in its corporate, clinical, and commercial initiatives, advancing its 5x30 growth strategy aimed at accelerating topline growth and transitioning into an innovative biopharmaceutical organization [4][5] Financial Highlights - Total revenues for Q2 2025 were $181.1 million, an increase from $178.0 million in Q2 2024 [11] - Net product sales included $142.9 million for EXPAREL, $31.3 million for ZILRETTA, and $5.6 million for iovera° [6] - The company reported a net loss of $4.8 million, or $0.11 per share, compared to a net income of $18.9 million, or $0.41 per share in Q2 2024 [11] - Adjusted EBITDA for Q2 2025 was $54.3 million, down from $62.1 million in Q2 2024 [11] Business Developments - The company surpassed 50% enrollment in its Phase 2 ASCEND study of PCRX-201 for knee osteoarthritis, with completion expected by the end of 2025 [7] - A new $300 million revolving credit facility was established to enhance liquidity and financial flexibility [7] - A co-promotion agreement with Johnson & Johnson MedTech aims to expand ZILRETTA's market reach [7] - Manufacturing efficiencies from large-scale EXPAREL production are expected to improve gross margins and inventory management [7] Legal and Patent Developments - A favorable court ruling resulted in a $28.3 million payment from the Research and Development Foundation [8] - The company secured additional patents for EXPAREL, extending exclusivity through 2041 and 2044 [8] Financial Guidance - The company updated its full-year 2025 revenue guidance to a range of $730 million to $750 million, while increasing non-GAAP gross margin guidance to 78-80% [19]
Pacira BioSciences Unveils Three-Year Clinical Data Following a Single Local Administration of Investigational Gene Therapy, PCRX-201, in Patients with Moderate-to-Severe Osteoarthritis of the Knee
Globenewswire· 2025-06-11 12:00
Core Insights - Pacira BioSciences, Inc. announced long-term follow-up data from its Phase 1 clinical trial of PCRX-201, a gene therapy for knee osteoarthritis, showing sustained clinical efficacy for up to three years [1][3][12] - The therapy demonstrated significant improvements in pain, stiffness, and function, with a single injection being well tolerated [1][7] Study Details - The Phase 1 trial involved 72 patients aged 30 to 80, with assessments conducted over 156 weeks using WOMAC and KOOS scores [4][6] - Participants were divided into two cohorts: one receiving varying doses of PCRX-201 and the other receiving a corticosteroid pretreatment [4] Key Findings - No serious treatment-related adverse events were reported, with treatment-related joint effusions occurring in 36% of the corticosteroid-pretreated group and 61% in the non-pretreated group [6][7] - Significant reductions in pain and stiffness were observed, with 51-53% reduction in WOMAC-A pain scores and 38-76% reduction in WOMAC-B stiffness scores [7] - Improvements in KOOS daily living function scores ranged from 26 to 28 points [7] Regulatory Designations - PCRX-201 received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency [8][9][12] - These designations facilitate efficient drug development and potential accelerated approval processes [9] Future Developments - Following promising Phase 1 results, a Phase 2 study (ASCEND study) is currently underway for PCRX-201 [10] - The therapy targets chronic inflammation at the cellular level, aiming to modify the disease rather than just alleviate symptoms [3][11]